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BLAKE 2232Recalls & reported problems

Ethicon Inc. · Blake Silicone Drain, 19 FR round, hubless with 1/4" bendable trocar · Class 1

Quick summary

This Ethicon Blake 2232 silicone round drain is a soft surgical drain placed in the abdomen or other body cavities to draw off fluid after surgery. Reports mostly describe fluid leaking or splashing from the drain, drainage that does not flow or cannot be suctioned properly, and packages arriving with hair or other foreign material inside. There are 68 reports, with 22 injuries and no deaths. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
71
Deaths reported
0
Injuries reported
22
Recalls naming it
0

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 10705031003606), received between Nov 22, 2017 and Sep 23, 2026 — classified as 22 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (26 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 2 reportsMar 2025: 2 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 2 reportsAug 2025: 0 reportsSep 2025: 4 reportsOct 2025: 1 reportsNov 2025: 1 reportsDec 2025: 2 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 3 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Leak/Splash26
  • Device Contaminated During Manufacture or Shipping11
  • Infusion or Flow Problem10
  • Break8
  • Material Integrity Problem7
  • Adverse Event Without Identified Device or Use Problem3
  • Appropriate Device Problem Term/Code Not Available3
  • Suction Problem2

Patient problems

  • No Clinical Signs, Symptoms or Conditions45
  • Insufficient Information8
  • No Consequences Or Impact To Patient7
  • Not Applicable6
  • Foreign Body In Patient4
  • Blood Loss3
  • Failure to Anastomose2
  • Hypoxia1

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 23, 2026Material Integrity Problem

    It was reported a patient underwent an unknown surgery on an unknown date and a drain was used. The blue stripe on the silicone drain was notably thin and faint in color when the package was opened. After surgery, the drain did not appear in the X-ray image. No additional procedures were performed, and the drain was removed on the scheduled date. There was no effect on the patient. Same product was used to complete the case. There were no adverse consequences to the patient. Further details are not provided.Upon receipt and analysis, product was found to be counterfeit.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50871262 ↗
  • MalfunctionSep 23, 2026Material Integrity Problem

    It was reported a patient underwent an unknown surgery on an unknown date and a drain was used. The blue stripe on the silicone drain was notably thin and faint in color when the package was opened. After surgery, the drain did not appear in the X-ray image. No additional procedures were performed, and the drain was removed on the scheduled date. There was no effect on the patient. Same product was used to complete the case. There were no adverse consequences to the patient. Further details are not provided.Upon receipt and analysis of additional sample, product was found to be counterfeit.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50871259 ↗
  • MalfunctionSep 23, 2026Material Integrity Problem

    It was reported a patient underwent an unknown surgery on an unknown date and a drain was used. The blue stripe on the silicone drain was notably thin and faint in color when the package was opened. After surgery, the drain did not appear in the X-ray image. No additional procedures were performed, and the drain was removed on the scheduled date. There was no effect on the patient. Same product was used to complete the case. There were no adverse consequences to the patient. Further details are not provided.Upon receipt and analysis of additional unused representative sample, product was found to be counterfeit.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50871253 ↗
  • MalfunctionMay 19, 2026Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. IT WAS FOUND THAT THERE WAS A FOREIGN MATTER LIKE A HAIR BEFORE THE PACKAGE WAS OPENED. THE PRODUCT WAS NOT USED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25221625 ↗
  • MalfunctionDec 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. IT WAS FOUND THAT THERE HAD BEEN A FOREIGN SUBSTANCE IN THE STERILE PACKAGE. THE PRODUCT IN QUESTION WAS UNOPENED. ANOTHER LIKE PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23896844 ↗
  • MalfunctionDec 3, 2025Leak/Splash; Infusion or Flow Problem; Leak/Splash; Infusion or Flow Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A DRAIN WAS USED. POST-OP AT THE WARDS/ICU, THE DRAIN CAME OFF FROM THE RESERVOIR. THE SUCTION ALSO COULD BE FELT DIFFICULT AND THE SUCTION COULD NOT BE DONE WELL, AS USUAL. ACCORDING TO THE NURSE, THE GROOVE OF THE DRAIN, WHICH IS USUALLY PLACED INSIDE THE ABDOMINAL CAVITY, WAS OUTSIDE THE ABDOMEN, SO SUCTION MIGHT NOT HAVE WORKED PROPERLY. THE HOSPITAL ASKED TO CHECK WHETHER THERE WAS ANY DAMAGE TO THE RESERVOIR OR THE DRAIN. THEY SAID THAT IF THERE IS NO PROBLEM WITH THE PRODUCT, IT WAS LIKELY A HANDLING ERROR ON THEIR SIDE. THERE WAS NO SURGICAL PROCEDURE, SUCH AS PLACING THE DRAIN AGAIN, WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23706115 ↗
  • InjuryNov 10, 2025Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL SURGERY ON (B)(6) 2025 AND A DRAIN WAS USED. DURING THE PROCEDURE AT THE WARD/ICU, AFTER USING THE PRODUCT IN THE ABDOMINAL CAVITY, DRAINAGE MANAGEMENT WAS CARRIED OUT IN THE WARD. AROUND NOON ON (B)(6) 2025, DRAINAGE LEAKAGE OCCURRED FROM THE ARMPIT, AND NEGATIVE PRESSURE COULD NOT BE APPLIED, SO THE NURSE CONTACTED THE DOCTOR, NEGATIVE PRESSURE WAS APPLIED AGAIN, AND THE PATIENT WAS MONITORED. IT IS UNCLEAR WHICH PART IS "THE ARMPIT" THAT THEY MEANT. AS THE CONDITION OF NOT APPLYING NEGATIVE PRESSURE CONTINUED, A REPLACEMENT PRODUCT WAS USED, AND DRAINAGE MANAGEMENT CONTINUED WITHOUT ANY PROBLEM. THE PRODUCT THAT DID NOT APPLY NEGATIVE PRESSURE WAS TREATED AS DEFECTIVE AND HANDED OVER TO THE DISTRIBUTION AGENCY. REPLACING OF THE DRAIN WAS DONE AT THE WARD. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: Insufficient Information

    MAUDE report 23509656 ↗
  • MalfunctionOct 22, 2025Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND A DRAIN WAS USED. DURING THE PROCEDURE, AT THE OUTPATIENT/TREATMENT ROOM, ALTHOUGH DRAINAGE WAS POSSIBLE, THERE WAS A HOLE IN THE DRAIN WHEN THE PATIENT WAS RETURNING TO THE WARDS FROM THE ICU, AND THE HOLE WAS DISCOVERED BECAUSE EXUDATE WAS LEAKING. AFTER THE OPERATION, WHILE THE PATIENT WAS IN THE ICU, THE AMOUNT OF DRAINAGE WAS ZERO. THE PATIENT'S PROGNOSIS IS GOOD. THE HOLE WAS A ROUND WOUND. THE TUBE WAS HELD WITH NON-TOOTHED FORCEPS, SO IT IS UNLIKELY THAT DAMAGE WAS CAUSED BY GRASPING. AS A MEASURE TAKEN AFTER THE EVENT OCCURRED, THE AREA THAT THE HOLE IN THE DRAIN WAS CUT AND RECONNECTED TO THE CHEST DRAIN BAG. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23361308 ↗
  • MalfunctionSep 19, 2025Leak/Splash; Leak/Splash

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN WAS DAMAGED AND LEAKED FLUID WHEN SUCTIONED. AS THIS WAS FOUND OUTSIDE THE OPERATING ROOM, THE LOT NUMBER IS UNKNOWN, BUT THE DAMAGED AREA WAS REINFORCED WITH COVERING MATERIAL AND THE PRODUCT WAS USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23096014 ↗
  • MalfunctionSep 15, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. IT WAS FOUND THAT THERE HAD BEEN A STAIN ON THE STERILIZED PACKAGING. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. . THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23056695 ↗
  • MalfunctionSep 15, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. IT WAS FOUND THAT THERE HAD BEEN A STAIN ON THE STERILIZED PACKAGING. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. . THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23056683 ↗
  • MalfunctionSep 4, 2025Infusion or Flow Problem; Infusion or Flow Problem

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A DRAIN WAS USED. DRAIN NOT CONNECTED AND PLUG-IN VALVE IS BROKEN. NO FURTHER DETAILS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22962119 ↗
  • MalfunctionJul 22, 2025Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025 AND A DRAIN WAS USED. THE DRAIN HAD ADHERED TO THE TROCAR NEEDLE. A PIECE OF THE TUBE ABOUT 1MM WAS ADHERED TO THE TROCAR NEEDLE WHEN SEPARATED THEM. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THIS EVENT WAS FOUND BEFORE USE. WHEN WE SEND THE SAMPLE TO YOU, WE WILL LET YOU KNOW ITS RETURN DATE AND TRACKING NUMBER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. UPON RECEIPT AND ANALYSIS, THERE WAS A STICKING MARK VISIBLE ON TROCAR.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22565937 ↗
  • MalfunctionJul 7, 2025Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN LAPAROSCOPIC SURGERY ON (B)(6) 2025 AND A DRAIN WAS USED. THE ADAPTER WAS BROKEN WHEN INSTALLING IT., THE EVENT HAD NEVER OCCURRED BEFORE, BUT IT SEEMS LIKELY THAT THE ADAPTER BROKE DUE TO THE RESULT OF FORCE BEING APPLIED IN A STRANGE DIRECTION, OR THAT THE CONNECTION METHOD WAS NOT DONE PROPERLY. THE PRODUCT WAS USED ON THE DRAIN OF THE PELVIC FLOOR. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. UPON RECEIPT AND ANALYSIS IT WAS NOTED THAT THE ADAPTER WAS CUT/DAMAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22412571 ↗
  • MalfunctionMar 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL SURGERY ON (B)(6) 2025 AND DRAIN WAS USED. WHEN OPENING THE PACKAGE, IT WAS FOUND THAT THERE WAS A HUMAN HAIR INSIDE THE STERILIZATION PACKAGE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21700724 ↗
  • InjuryMar 18, 2025Leak/Splash; Leak/Splash

    IT WAS REPORTED A PATIENT UNDERWENT AN OPEN CORONARY ARTERY BYPASS GRAFTING SURGERY ON AN (B)(6) 2025 AND A DRAIN WAS USED. IN WARDS/ICU, IT WAS FOUND THAT THERE WAS A CRACK ON THE MIDDLE OF THE DRAIN, AND A LEAK OCCURRED. A REPLACEMENT DRAIN WAS PUT OUT, SO THE PATIENT HAD NO PROBLEMS AT ALL. THE PRODUCT WAS USED ON THE CHEST. IT IS THOUGHT SOMETHING HAPPENED DURING THE PROCEDURE IN THE HOSPITAL THAT CAUSED THE DAMAGE. NO SAMPLE WILL BE RETURNED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. NO PRODUCT RETURNING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21630252 ↗
  • InjuryFeb 24, 2025Break; Leak/Splash; Break; Leak/Splash

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN RESPIRATORY PROCEDURE ON (B)(6) 2025 AND A DRAIN WAS USED. IN THE WARD/ICU, THE 19FR DRAIN WAS PLACED IN THE RIGHT CHEST AT THE SURGERY ON (B)(6) 2025. A LEAK OCCURRED ON (B)(6) 2025 IN THE MORNING. WHEN THE ADHESIVE MEDICINE WAS ADMINISTERED FROM THE DRAIN, LEAKAGE OF THE MEDICINE WAS FOUND, SO THE DOCTOR USED BOLHEAL THROUGH THE DRAIN. WHEN THAT BOLHEAL LEAKED FROM NEAR THE DRAIN CUT AREA, THE DOCTOR NOTICED THAT THE DRAIN MAY HAVE BEEN DAMAGED, AND PROCEEDED TO COVER THE DRAIN WITH GAUZE AND ETC. AFTER THAT, A DRAIN WAS COMPLETELY CUT OFF ON (B)(6) 2025, IT WAS FOUND THAT THE DRAIN WAS BROKEN ON (B)(6) 2025. THE REMAINING DRAIN INSIDE OF THE BODY WAS REMOVED UNDER LOCAL ANESTHESIA ON (B)(6) 2025. AFTER THE DRAIN WAS REMOVED, THE DRAIN WAS NOT RE-PLACED AND SO ON, THE PATIENT'S CONDITION WAS UNEVENTFUL AND THE PATIENT WAS DISCHARGED ON (B)(6) 2025. NO HEALTH DAMAGE WAS OBSERVED AFTERWARDS. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Foreign Body In Patient

    MAUDE report 21453048 ↗
  • MalfunctionFeb 11, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2025 AND A DRAIN WAS USED. AFTER OPENING THE STERILE PACKAGE, IT WAS CONFIRMED THAT THE HUMAN HAIRS WERE WOUND AROUND THE DRAIN. THE PRODUCT WAS NOT USED FOR THE PATIENT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21358259 ↗
  • InjuryJan 6, 2025Break; Break

    IT WAS REPORTED A PATIENT UNDERWENT AN ABDOMINOPLASTY ON (B)(6)2024 AND A DRAIN WAS USED. THE DRAIN BREAKAGE OCCURRED. DURING ITS REMOVAL. LEAVING IN ABDOMINAL CAVITY AND HAVING TO RE-INTERVENE. PROCEDURE DELAYED 30MINUTES. DUE TO ELAPSED TIME CANNOT KNOW THE LOT NUMBER OR EXPIRATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Foreign Body In Patient

    MAUDE report 21085192 ↗
  • MalfunctionNov 8, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN SURGERY ON (B)(6) 2024 AND A DRAIN WAS USED. IT WAS FOUND THAT THERE HAD BEEN A FOREIGN MATTER IN THE PACKAGE. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20641268 ↗
  • InjuryOct 24, 2024Leak/Splash; Leak/Splash

    IT WAS REPORTED A PATIENT UNDERWENT AN AVR AND CABE ON (B)(6) 2024 AND A DRAIN WAS USED. DURING SURGERY, THE DRAIN WAS DAMAGED AT 20 CM FROM THE DRAIN INSERTION WHEN MILKING A SUB THORACIC DRAIN WITH ALCOHOL COTTON AT THE WARD AFTER THE SURGERY. DRAIN WAS REPLACED. PATIENT IS STABLE. FURTHER DETAILS ARE NOT PROVIDED, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Insufficient Information

    MAUDE report 20523599 ↗
  • MalfunctionJul 18, 2024Obstruction of Flow; Obstruction of Flow

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN OB-GYN SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. THE DRAIN WAS BROKEN AND NOT SUCTIONED. THE PATIENT WAS FEMALE. FURTHER DETAILS ARE NOT PROVIDED. NO ADVERSE EVENT, BUT THE PATIENT HAD TO BE HAVE TREATMENT OF REMOVAL THE DRAIN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19774149 ↗
  • MalfunctionJun 10, 2024Leak/Splash; Leak/Splash

    IT WAS REPORTED A PATIENT UNDERWENT CARDIOVASCULAR SURGERY ON AN UNKNOWN DATE AND A DRAIN WAS USED. IT HAD BEEN MANAGED WASTE FLUID IN THE ICU, THE DRAIN BECAUSE OF THE AIR LEAK, IT WAS FOUND THAT A SMALL HOLE. IT HAD BEEN A POSSIBILITY OF LEAK, SO REPLACED THE NEW PRODUCT. IT WAS NOT HEALTH INJURY. FURTHER DETAILS ARE NOT PROVIDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEE REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19498410 ↗
  • MalfunctionFeb 28, 2024Leak/Splash; Leak/Splash

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. IN THE WARD / ICU, THE SURGEON NOTICED THE BREAKAGE OF THE DRAIN WHEN HE WAS PROBABLY MILKING IT WITH AN ALCOHOL SWAB. IMMEDIATELY AFTER THAT, IT WAS CLAMPED AND THERE WERE NO PROBLEMS FOR THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18799932 ↗
  • InjuryNov 6, 2023Break; Break

    IT WAS REPORTED A PATIENT UNDERWENT MILES' SURGERY ON (B)(6) 2023 AND A DRAIN WAS USED. A 19FR DRAIN WAS INSERTED 5CM TO THE LEFT FROM THE ANUS DURING. THE CT SCAN ON (B)(6) 2023 CONFIRMED THAT THE DRAIN WAS IN PLACE WITHOUT DISCONNECTION. THE CT SCAN ON (B)(6) 2023 SHOWED THAT THE DRAIN WAS DISCONNECTED. THE DRAIN WAS REMOVED ON (B)(6) 2023. THE SURGEON COMMENTED THE FOLLOWING. BECAUSE THERE WAS A SUSPICION OF RECURRENCE AND A BIOPSY WAS TO BE PERFORMED, AND WHEN THE CT IMAGES WERE REVIEWED ((B)(6) 2023), IT WAS NOTICED THAT THE DRAIN REMAINED IN THE BODY. THE CT SCAN SHOWED THAT THE TIP OF THE DRAIN HAD NOT MOVED, AND WE SUSPECTED THAT THE DRAIN WAS THE CAUSE OF THE PROBLEM. THERE WERE NO CONCERNS ABOUT THE POSTOPERATIVE DRAINAGE (CHARACTERISTICS AND VOLUME). THERE WAS NO INTERNAL FIXATION OF THE DRAIN. EXTRACORPOREAL FIXATION WAS PERFORMED WITH SILK. THERE WERE NO PROBLEMS WITH THE PATIENT REGARDING THE REMAINING DRAIN, AS A BIOPSY WAS NECESSARY DUE TO SUSPICION OF RECURRENCE. THERE WAS NO CHANGE IN THE PATIENT'S PHYSICAL CONDITION. [CURRENT STATUS OF THE PATIENT] THE PATIENT IS IN HOSPITAL. [PROGRESS] THERE IS NO CHANGE IN THE PATIENT'S CONDITION ASSOCIATED WITH RESIDUAL DRAINA

    Patient problems: Foreign Body In Patient

    MAUDE report 18080949 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.