Cook TPN G07903Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00827002079038), received between Aug 29, 2016 and Jul 16, 2020 — classified as 14 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (15 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2020Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 10284116 ↗
• MalfunctionFeb 24, 2020Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE CATHETER OF A REDO SINGLE LUMEN TPN CATHETER SET "CAME APART AT THE VOLUME SHEATH". THE SHEATH CAN BE "ROTATED SIDE TO SIDE". NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9744475 ↗
• MalfunctionMay 24, 2019Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8639657 ↗
• MalfunctionMar 8, 2018Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE BASE OF THE THORAX REDO SINGLE LUMEN TPN CATHETER WAS PARTIALLY BROKEN. THE CUSTOMER DESCRIBED THE BREAK AS A RUPTURE OF ABOUT 5 CM IN SIZE, WHICH WAS OBSERVED TO EXIST AT THE POINT WHERE THE CATHETER EXITS FROM THE PATIENT'S SKIN. THE PATIENT'S CHEMOTHERAPY WAS SUSPENDED FOR 12 HOURS AS A RESULT, AND THE PATIENT CONTACT CALLED THE SURGEON TO FIX IT WITH A REPAIR KIT. THE CATHETER HAD ORIGINALLY BEEN IMPLANTED ON (B)(6) 2017. THE CATHETER WAS NOT USED IN A HIGH FLOW OR POWER INJECTION INDICATION, AND THE SYRINGE USED TO FLUSH THE CATHETER WAS NEVER LESS THAN 10 ML. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7325519 ↗
• InjuryFeb 6, 2018Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING THE FLUSHING OF THE CATHETER WHICH WAS PERFORMED BY THE PATIENT CONTACT, THE REDO SINGLE LUMEN TPN CATHETER BROKE AND LEAKED HEPARIN. THE CATHETER HAD BEEN REPAIRED PREVIOUSLY, AND THE REPORTED BREAK WAS LOCATED NEAR THE SITE OF THE REPAIR. THE CATHETER LINE WAS CLAMPED TO AVOID BLEEDING, AND ATTEMPTS TO GET A NEW LINE PLACED WERE MADE. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Code Available

  MAUDE report 7246326 ↗
• MalfunctionJan 9, 2018Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE REDO SINGLE LUMEN TPN CATHETER "SECTIONED AFTER THE SAFETY LOOP WHEN THE PATIENT GOT UP" AND "WAS CUT BY ACCIDENT" [SIC]. THIS RESULTED IN AN INTERRUPTION OF THE "SAL TRANSFUSION" [SIC] IN PROGRESS FOR AN HOUR, AND ADDITIONALLY NECESSITATED THE PLACEMENT OF A PERIPHERAL VENOUS ACCESS FOR INFUSING TREATMENTS WHILE THE CATHETER WAS REPAIRED. THE PATIENT REPORTEDLY DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE PRODUCT MALFUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, BUT NONE HAS YET BEEN MADE AVAILABLE. THE DEVICE IS REPORTEDLY NOT AVAILABLE FOR RETURN AND EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7176671 ↗
• MalfunctionJan 9, 2018Material Deformation; Material Deformation

  THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN THE NURSE WAS EXAMINING THE REDO SINGLE LUMEN TPN CATHETER, A "DILATATION ON THE CATHETER" [SIC] WAS NOTED. A REPAIR OF THE CATHETER HAD BEEN PERFORMED PREVIOUSLY, AND THE NEWLY OBSERVED DEFECT WAS REPORTEDLY NEAR THE LOCATION OF THE PREVIOUS ONE. A SECOND REPAIR WAS PERFORMED, AND A PERIPHERAL VENOUS ACCESS FOR INFUSING TREATMENTS WAS ADDITIONALLY PLACED AND USED OVER THE COURSE OF THE REPAIR. NO PATIENT ADVERSE EVENTS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, BUT NONE HAS YET BEEN RECEIVED. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7176669 ↗
• MalfunctionDec 12, 2017Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE REDO SINGLE LUMEN TPN CATHETER ACCIDENTALLY BROKE WHEN THE PATIENT STEPPED ON THE LINE, WHICH RESULTED IN A DELAY IN THE ADMINISTRATION OF THE PATIENT'S TREATMENT. ALTHOUGH IT IS NOT KNOWN WHAT THE CUSTOMER DID TO CORRECT THE ISSUE, THE CUSTOMER CONFIRMED THAT NO ADDITIONAL PROCEDURES WERE REQUIRED, AND NO PATIENT ADVERSE EVENTS OCCURRED AS A RESULT. THE DEVICE IS NOT AVAILABLE FOR RETURN AND EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7108244 ↗
• InjuryNov 7, 2017Break; Break

  THE INTERNATIONAL CUSTOMER INITIALLY REPORTED AN UNSPECIFIED ISSUE WITH THE REDO SINGLE LUMEN TPN CATHETER SET. THE ISSUE REPORTEDLY MADE THE PATIENT NERVOUS. A COMPLAINT FORM WHICH WAS LATER RECEIVED FURTHER CLARIFIED THE ISSUE, WHICH WAS THAT THE CENTRAL VENOUS CATHETER BROKE WHERE IT WAS CLAMPED. INFORMATION WAS FURTHER PROVIDED IN AN INCIDENT REPORT WHICH WAS RECEIVED FROM THE (B)(6) AND TRANSLATED: THE CATHETER WAS "USED FOR HEMATIC SAMPLING, THERAPY, TRANSFUSION, HYDRATATION" [SIC]. THE FORM ALSO SPECIFIED A "SPECIFIC SURGICAL PROCEDURE" AS A CONSEQUENCE OF THE PRODUCT PROBLEM. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO PRODUCT HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 7006688 ↗
• MalfunctionNov 1, 2017Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE REDO SINGLE LUMEN TPN CATHETER BROKE IN THE THINNEST PORTION OF THE DEVICE. THE CIRCUMSTANCES SURROUNDING THE HANDLING AND USAGE OF THE DEVICE ARE NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6993026 ↗
• MalfunctionSep 11, 2017Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT, WITHOUT ANY EXCESSIVE FORCE, THE REDO SINGLE LUMEN TPN CATHETER WAS LEAKING FLUID. THE FLUID WAS COMING FROM A BREAK IN THE LINE THAT REPORTEDLY OCCURRED IN THE THINNEST PORTION OF THE DEVICE. NO ADDITIONAL PROCEDURES OR PATIENT ADVERSE EVENTS WERE REPORTED. THE CIRCUMSTANCES SURROUNDING THE HANDLING AND USAGE OF THE DEVICE ARE NOT KNOWN. THE CUSTOMER HAS INDICATED THAT THE DEVICE WILL NOT BE RETURNING FOR EVALUATION. ADDITIONAL INFORMATION WAS LATER RECEIVED IN A RESPONSE TO A FOLLOW UP REQUEST FOR ADDITIONAL INFORMATION WHICH CONFIRMED THAT THE PATIENT WAS (B)(6) YEARS OLD. ADDITIONALLY, THIS DEVICE WAS REPAIRED USING THE DEVICE CAPTURED UNDER MEDICAL DEVICE REPORT #: 1820334-2017-02633. AFTER FURTHER REVIEW OF THE RECORD, IT WAS DETERMINED THAT ACCORDING TO THE CUSTOMER, THE EVENT RESULTED IN AN INTERRUPTION OF HYDRATION TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6854704 ↗
• InjuryAug 9, 2017Break; Break

  REPORT RECEIVED VIA FDA REPORT MW5070898 STATING: COOK CENTRAL CATHETER BROKE WHERE THE THINNER, SMALLER TUBE CONNECTS WITH THE LARGER PORTION OF THE CATHETER WHILE THE PATIENT WAS AT HOME. THE PATIENT RETURNED TO THE HOSPITAL, WHERE THE LINE WAS REMOVED AND REPLACED. NO FURTHER INFORMATION WAS PROVIDED. INITIAL REPORTER CONTACT INFORMATION WAS NOT PROVIDED, ACCORDINGLY, NO FOLLOW-UP CAN BE CONDUCTED.

  Patient problems: No Code Available

  MAUDE report 6777423 ↗
• MalfunctionAug 8, 2017Break; Material Twisted/Bent

  THE COMPLAINANT NOTED THAT THE CATHETER BROKE AFTER BEING TWISTED. THIS PRODUCT PROBLEM OCCURRED PRIOR TO PATIENT CONTACT SO THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6774382 ↗
• MalfunctionAug 8, 2017Break; Material Twisted/Bent

  THE COMPLAINANT NOTED THAT THE CATHETER BROKE AFTER BEING TWISTED. THIS PRODUCT PROBLEM OCCURRED PRIOR TO PATIENT CONTACT SO THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6774322 ↗
• MalfunctionAug 8, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT RECEIVED A REDO SINGLE LUMEN TOTAL PARENTERAL NUTRITION (TPN) CATHETER ON AN UNSPECIFIED DATE. THE PATIENTS MOTHER REPORTED TO THE NUTRITIONAL SERVICE THAT THE TOP PART OF THE CENTRAL VENOUS CATHETER BECAME SEPARATED. THE EVENT OCCURRED AT THE HOME OF THE PATIENT. THE ACTIONS TAKEN BY THE CLINICAL NUTRITIONAL STAFF ARE NOT KNOWN. THERE ARE NO REPORTS OF ANY MEDICAL OR SURGICAL INTERVENTION TO ADDRESS THIS EVENT. THERE ARE NO KNOWN ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6773568 ↗
• MalfunctionAug 7, 2017Split

  DURING INSERTION OF A BROVIAC CATHETER TPN SINGLE LUMEN, THE CATHETER SPILT IT IN TWO PRIOR TO COMPLETING INSERTION. THE CATHETER WAS REMOVED FROM THE FIELD. THERE WERE NO INJURIES OR ADDITIONAL MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6771304 ↗
• InjuryJul 31, 2017Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE CATHETER RUPTURED IN TWO DIFFERENT LOCATIONS: TOWARDS THE MIDDLE, AS WELL AS IN THE CONIC REGION OF THE DEVICE. THE OPERATOR REPORTEDLY CHANGED OUT THE DEVICE, WHICH INCREASED THE RISK TO WHICH THE PATIENT WAS EXPOSED. THE PRODUCT WAS REPORTEDLY UNAVAILABLE FOR RETURN.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6754276 ↗
• MalfunctionJul 12, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT RECEIVED A REDO SINGLE LUMEN TPN CATHETER ON (B)(6) 2017 FOR CANCER CHEMOTHERAPY. THE PATIENT WAS IN THE CARE OF GRANDPARENTS. THE CARETAKERS PICKED UP THE PATIENT AND STEPPED ON THE LINES CONNECTED TO THE CATHETER CAUSING THE CATHETER TO BREAK. NO FURTHER PATIENT OR EVENT DETAILS ARE AVAILABLE. IT IS NOT KNOWN IF THE DEVICE IS AVAILABLE FOR EVALUATION. IT IS NOT KNOWN WHAT ACTIONS WERE TAKEN BY THE CLINICAL STAFF TO ADDRESS THIS EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6705590 ↗
• MalfunctionJun 21, 2017Material Rupture; Material Rupture

  INTERNATIONAL CUSTOMER REPORTED THAT A PEDIATRIC PATIENT RECEIVED A REDO SINGLE LUMEN TOTAL PARENTERAL NUTRITION (TPN) CATHETER ON AN UNSPECIFIED DATE. THE PATIENT WAS UNDERGOING PARENTERAL NUTRITION FOR AN INDICATION RELATED TO DIGESTIVE HEMORRHAGES. THE PATIENT'S MOTHER CONTACTED THE PEDIATRIC AUXILIARY ON (B)(6) 2017 REPORTING THAT THE CATHETER WAS 'DISASSOCIATED.' THE NURSE EXAMINED THE DEVICE AND FOUND A RUPTURE OF THE CATHETER NEAR THE CLAMP, HOWEVER THE PLASTER WAS STILL CLEAN, SEALED AND THE PROTECTIVE LOOP WAS STILL IN PLACE. THE NURSE REPORTS THIS MEANS THAT THE CATHETER WASN'T PULLED. THE CHILD WAS REPORTED AS CALM AND NOT IN PAIN. THERE IS NO REPORT OF ANY INTERVENTION TO ADDRESS THIS EVENT AS OF THE DATE OF THIS REPORT. THE DEVICE IS NOT AVAILABLE FOR EXAMINATION. ADDITIONAL INFORMATION WAS REQUESTED; NO FURTHER INFORMATION WAS RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ANY ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6657231 ↗
• InjuryMay 5, 2017Break; Break

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A REDO SINGLE LUMEN TPN CATHETER ON AN UNKNOWN DATE FOR TOTAL PARENTERAL NUTRITION (TPN). CUSTOMER REPORTED THAT THE OUTER SHEATH OF THE DEVICE BROKE. THE DEVICE WAS PREVIOUSLY REPAIRED AT AN UNKNOWN TIME. THE SITE OF THE BREAK ALONG THE CATHETER LENGTH IS NOT KNOWN. THE CIRCUMSTANCES AND HANDLING CONDITIONS LEADING UP TO THE EVENT ARE NOT KNOWN. THE DEVICE WAS COMPLETELY EXPLANTED AND REPLACED. IT IS NOT KNOWN IF THE DEVICE IS AVAILABLE FOR EXAMINATION.

  Patient problems: No Code Available

  MAUDE report 6547024 ↗
• InjuryDec 20, 2016Leak/Splash; Leak/Splash

  THE CATHETER WAS LEAKING AT HUB, AND SITE WAS TENDER TO TOUCH AND RED. LINE WAS REPLACED WITH A NEW LINE.

  Patient problems: No Code Available

  MAUDE report 6190579 ↗
• InjuryDec 20, 2016Material Separation; Material Separation

  IT WAS REPORTED A TOTAL PARENTERAL NUTRITION (TPN) CATHETER PLACED (B)(6) 2016, WAS REPAIRED ON 01 NOVEMBER 2016 BECAUSE THE EXTERNAL SHEATH DISCONNECTED AT THE LEVEL OF THE BASE AND THE INTERNAL SHEATH WAS VISIBLE. ABLATION ON (B)(6) 2016 BECAUSE THE CATHETER SECTIONED ON THE PART REPLACED DURING REPAIR. THERE WAS NO SPECIAL TRACTION AND NO MODIFICATION OF THE SAFETY LOOP USUALLY DONE UNDER THE BANDAGE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE: REPAIRING THE CATHETER, MONITORING BIOLOGICAL PARAMETERS OF THE CHILD AND REPLACING THE CATHETER.

  Patient problems: No Code Available

  MAUDE report 6190204 ↗
• InjuryDec 19, 2016Break; Break

  IT WAS REPORTED A CATHETER PLACED ON (B)(6) 2016 REQUIRED BEDSIDE REPAIR ON (B)(6) 2016 BECAUSE THE CATHETER, ¿CRACKED AT THE JUNCTION BETWEEN THE LARGE AND THIN PART OF THE CATHETER.¿ THE CHILD¿S BIOLOGICAL PARAMETERS WERE MONITORED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING PATIENT OUTCOME AT THE TIME OF THIS REPORT NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6185269 ↗
• MalfunctionDec 19, 2016Crack; Crack

  IT WAS REPORTED A CATHETER PLACED ON (B)(6) 2016 WAS REMOVED DUE TO AN INFECTION OF UNKNOWN ORIGIN. UPON EXAMINATION OF THE REMOVED CATHETER THE PHYSICIAN NOTED THE DEVICE WAS ¿FRAGILE AT THE JUNCTION BETWEEN THE LARGE & THIN PART OF THE CATHETER SO SHE DECIDED TO TEST IT AND PULLED IT OUT A LITTLE BIT ON THE EXTREMITY IT, THEN IT CRACKED.¿ A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6184879 ↗
• InjuryDec 16, 2016Crack; Crack

  IT WAS REPORTED THE CUSTOMER HAD BEEN HAVING DIFFICULTY WITH THE CATHETER AND REPAIR KITS BEING USED ON THIS PATIENT. THIS IS ONE OF 3 REPORTS BEING FILED FOR DISSATISFACTION OF ALLEGED CRACKING OF THE CATHETER IN RELATIONSHIP TO THE 1ST REPORT FILED UNDER MEDWATCH# 1820334-2016-01369. THE ORIGINAL MEDWATCH ALLEGED A, ¿(B)(6) YEARS OLD WAS BEING LIFTED OUT OF A STROLLER AND THE CATHETER CUT AT THE JUNCTION BETWEEN THE THIN PORTION AND THE ENLARGED PORTION OF THE CATHETER. A REPAIR KIT WAS USED ON THE CATHETER.¿ MONITORED THE BIOLOGICAL PARAMETERS OF THE CHILD. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING PATIENT OUTCOME. THE THREE ADDITIONAL REPORTS ARE: MEDWATCH 1820334-2016-01480 (THIS REPORT INCIDENT #2). MEDWATCH 1820334-2016-01478 (INCIDENT #3). MEDWATCH 1820334-2016-01479 (INCIDENT#4).

  Patient problems: No Code Available

  MAUDE report 6180298 ↗