Argyle 8888160333 (UDI 20884527005113)Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 20884527005113), received between Nov 9, 2016 and Sep 17, 2026 — classified as 2 deaths, 9 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Break” (21 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Leak/Splash

  Patient problems: Hypoglycemia

  MAUDE report 50809825 ↗
• MalfunctionDec 24, 2025Break; Break

  THE CUSTOMER REPORTED THAT 3.5FR SINGLE LUMEN CATHETER WAS DROPPED ON TO THE STERILE FIELD. IT WAS NOTED THAT THE END OF CATHETER WHERE THE STOPCOCK WOULD BE CONNECTED HAD BROKEN OFF. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888242 ↗
• MalfunctionFeb 24, 2025Break; Leak/Splash; Break; Leak/Splash

  THE CUSTOMER REPORTED A DEVICE FAILURE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE LINE WAS PULLED OUT 1 CM WITHOUT THE USE OF ANY TWEEZERS OR SCISSORS AND WITHOUT REPORTED TENSION. THE LINE IMMEDIATELY STARTED LEAKING AND EVENTUALLY WAS DISCOVERED TO BE DUE TO A SLIT IN THE CATHETER. THERE WAS AN IVF (INTRAVENOUS FLUID) AND BLOOD LOSS. PER CUSTOMER, BLOOD SUGAR WAS DROPPED HOWEVER, DID NOT REQUIRE A TREATMENT. NO ANEMIA OR HYPOVOLEMIA OBSERVED. THERE WAS A CONCERN FOR INTRODUCTION OF INFECTION AND CBC WAS CHECKED AND IT WAS WITHIN NORMAL LIMITS. THERE WAS NO PATIENT HARM REPORTED. THE DEVICE WAS REMOVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypoglycemia

  MAUDE report 21454753 ↗
• InjuryFeb 20, 2025Break; Break

  THE CUSTOMER REPORTED THAT THE UAC NOTICED TO BE SHORT UPON REMOVAL. AN X-RAY CONFIRMED THE UAC RETENTION. A NEW 3.5FR UAC CATHETER IDENTICAL TO THE ONE USED ON THE PATIENT WAS TESTED. IT WAS STRETCHED WITH SIGNIFICANT FORCE TO ASSESS FRAGILITY. THE CATHETER DID NOT BREAK. THE ASSESSMENT IS THAT THE UAC DISSECTED UPON REMOVAL AS IT WAS COMPROMISED OR DEFECTIVE IN SOME WAY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE BABY HAD AN UMBILICAL EXPLORATION WHICH FAILED AND A BESIDE EXPLORATORY LAPAROSTOMY WAS PERFORMED WHERE THE CATHETER WAS FOUND AND REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21422597 ↗
• MalfunctionJan 8, 2025Break; Break

  THE CUSTOMER REPORTED THAT ON (B)(6)2024, WHEN TRYING TO DISLODGE THE UMBILICAL TIE ON THE BABY CORD STUMP, THE UMBILICAL CATHETER BROKE, AND A FINGER LENGTH LEFT INSIDE THE BABY WITH THE TIP SEEN ON THE STUMP. PER CUSTOMER, THE DOCTOR RIGHT AWAY PULLED IT OUT USING THE TWEEZER.

  Patient problems: Foreign Body In Patient

  MAUDE report 21102365 ↗
• MalfunctionOct 29, 2024Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THE POLYURETHANE UMBILICAL VESSEL CATHETER 3.5FR SINGLE LUMEN WAS UNABLE TO CONNECT TO STOPCOCK. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558623 ↗
• MalfunctionOct 15, 2024Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THE CATHETER WAS DEFECTIVE. PER CUSTOMER, THERE SEEMS TO BE A PROBLEM WITH THE LUER PORTION OF THE CATHETER. WHEN PLACING A NEGATIVE PRESSURE CAP ON THE END OF THE CATHETER, THE CAP CONTINUES TO SPIN AND NEVER "LOCKS" IN PLACE AND THEN IS EASILY PULLED OFF. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20457996 ↗
• MalfunctionOct 15, 2024Break; Connection Problem; Break; Connection Problem

  PER CUSTOMER, THE NURSING STAFF REPORTED THAT THE TUBING WOULD NOT ATTACH SECURELY TO UMBILICAL LINE. THE HUB OF LINE FOUND TO BE BROKEN. THE ISSUE WAS REPORTED TO THE PROVIDER AND THE LINE WAS REMOVED SINCE IT WAS UNABLE TO SECURELY CONNECT. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20457864 ↗
• MalfunctionOct 15, 2024Break; Connection Problem; Break; Connection Problem

  PER CUSTOMER, THE NURSING STAFF REPORTED THAT THE TUBING WOULD NOT ATTACH SECURELY TO UMBILICAL LINE. THE HUB OF LINE FOUND TO BE BROKEN. THE ISSUE WAS REPORTED TO THE PROVIDER AND THE LINE WAS REMOVED SINCE IT WAS UNABLE TO SECURELY CONNECT. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20457790 ↗
• MalfunctionOct 15, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT WHEN THE UMBILICAL CATHETER WAS FLUSHED, A HOLE AT THE 20CM MARK WAS OBSERVED, SO IT WAS REMOVED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452518 ↗
• MalfunctionOct 1, 2024Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THE 3.5 FR SINGLE LUMEN COVIDIEN UMBILICAL CATHETER WAS DEFECTIVE. PER CUSTOMER, THERE SEEMS TO BE A PROBLEM WITH THE LUER PORTION OF THE CATHETER. WHEN PLACING A NEGATIVE PRESSURE CAP ON THE END OF THE CATHETER, THE CAP CONTINUES TO SPIN AND NEVER "LOCKS" IN PLACE AND THEN IS EASILY PULLED OFF. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20345052 ↗
• MalfunctionSep 25, 2024Obstruction of Flow; Obstruction of Flow

  CUSTOMER REPORTS: THE SINGLE LUMEN UAV CATHETER WAS FAULTY. A TERM INFANT WITH SEVERE PPHN (PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN) REQUIRING UAC AFTER ADMISSION. THE ASSESSMENT NOTES: APP'S ATTEMPTING TO PLACE 3.5FR UAC. CATHETER WAS FLUSHED WITH HEPARINIZED NORMAL SALINE PRIOR TO INSERTION PER POLICY. CATHETER WAS THEN INSERTED WITH POSITIVE BLOOD RETURN. WHEN ATTEMPTING TO DRAW BLOOD SAMPLES FROM THE LINE, BLOOD WAS ABLE TO BE DRAWN BACK TO THE FUSE AND THEN STOPPED. APP'S WERE UNABLE TO DRAW ANY ADDITIONAL BLOOD BACK OR FLUSH ANY HEP. SALINE FORWARD. THE RECOMMENDATION WAS TO WITHDRAW THE LINE AND A NEW LINE WAS PLACED. THE FAULTY CATHETER WAS LEFT IN THE CARE OF APSM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304604 ↗
• MalfunctionAug 22, 2024Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT 3.5FR UMBILICAL CATHETER WAS PLACED. THE RN CONNECTED THE IVF¿S, AFTER CONNECTING EXTENSION PIECE/TRI-FUSE, THE END WOULD NOT LOCK INTO PLACE TO THE END OF THE CATHETER, IT WOULD KEEP TURNING AND EASILY DISCONNECT. MULTIPLE EXTENSION TUBING WAS TRIED, AND THEY ALL DID THE SAME, WOULD NOT LOCK INTO CATHETER. INSPECTION OF THE CATHETER TIP SHOWED TO TABS, WHEN COMPARED WITH OTHER 3.5FR CATHETERS THOSE HAD TWO TABS AND A LIP. THE UMBILICAL CATHETER WAS REPLACED, NO HARM TO THE PATIENT INVOLVED. THERE WAS ONLY DELAY IN HANGING IVF'S AND A SECOND CATHETER BEING PLACED. THE CUSTOMER ALSO STATED THAT TWIN B WAS GETTING LINES PLACED AT THE SAME TIME, THE CATHETER ASSESSED FOR THE SAME CATHETER TIP AND CHANGED PRIOR TO PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031133 ↗
• MalfunctionAug 14, 2024Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THEIR NEONATAL ICU SITE HAS INCORRECT CONNECTORS FOR THE 3.5FR SINGLE LUMEN UMBILICAL CATHETERS. THE HUB HAS TWO NOTCHES THAT DO NOT CONNECT WITH THEIR SYRINGES OR TUBING. WHILE TRYING TO CONNECT THE LINE, THE PRACTITIONERS KEPT TURNING THE CATHETER BUT WERE UNABLE TO GET IT TO CONNECT PROPERLY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT UNABLE TO FULLY SECURE A BD 5 ML SYRINGE ONTO UVC LUER ¿LUGS¿. THE ISSUE OCCURRED DURING 1ST ACCESS WITH SYRINGE. THE CUSTOMER VERIFIED MANUALLY AND NOTICED THAT THREADS WERE NOT ENGAGING WITH SYRINGE LUER. THE LUER LUGS APPEARED TO BE BENT AWAY FROM LUER, WHEN COMPARED WITH COMPONENT DESIGN. THE NURSES EVALUATED THE OTHER UVC PRODUCTS FROM THE SAME LOT AND CONNECTION WITH SYRINGE SEEMED TO FUNCTION AS INTENDED. THEY WERE ABLE TO SUCCESSFULLY CONNECT A SYRINGE OR OTHER DEVICE, WITHOUT AN ISSUE. A NURSE ALSO EVALUATED ATTACHING THE EXACT 5 ML SYRINGE USED IN THE REPORTED COMPLAINT TO ONE UVC LUER FROM THE SAME LOT (NOT THE SUBJECT OF COMPLAINT) AND SAID IT CONNECTED TO THE NEW UVC ACCEPTABLY AND NO ISSUE OBSERVED. THIS INFERS THAT THE SYRINGE USED WAS NOT TO BLAME. THERE WAS NO PATIENT HARM REPOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19988113 ↗
• MalfunctionAug 14, 2024Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THEIR NEONATAL ICU SITE HAS INCORRECT CONNECTORS FOR THE 3.5FR SINGLE LUMEN UMBILICAL CATHETERS. THE HUB HAS TWO NOTCHES THAT DO NOT CONNECT WITH THEIR SYRINGES OR TUBING. WHILE TRYING TO CONNECT THE LINE, THE PRACTITIONERS KEPT TURNING THE CATHETER BUT WERE UNABLE TO GET IT TO CONNECT PROPERLY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT UNABLE TO FULLY SECURE A BD 5 ML SYRINGE ONTO UVC LUER ¿LUGS¿. THE ISSUE OCCURRED DURING 1ST ACCESS WITH SYRINGE. THE CUSTOMER VERIFIED MANUALLY AND NOTICED THAT THREADS WERE NOT ENGAGING WITH SYRINGE LUER. THE LUER LUGS APPEARED TO BE BENT AWAY FROM LUER, WHEN COMPARED WITH COMPONENT DESIGN. THE NURSES EVALUATED THE OTHER UVC PRODUCTS FROM THE SAME LOT AND CONNECTION WITH SYRINGE SEEMED TO FUNCTION AS INTENDED. THEY WERE ABLE TO SUCCESSFULLY CONNECT A SYRINGE OR OTHER DEVICE, WITHOUT AN ISSUE. A NURSE ALSO EVALUATED ATTACHING THE EXACT 5 ML SYRINGE USED IN THE REPORTED COMPLAINT TO ONE UVC LUER FROM THE SAME LOT (NOT THE SUBJECT OF COMPLAINT) AND SAID IT CONNECTED TO THE NEW UVC ACCEPTABLY AND NO ISSUE OBSERVED. THIS INFERS THAT THE SYRINGE USED WAS NOT TO BLAME. THERE WAS NO PATIENT HARM REPO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19987842 ↗
• MalfunctionAug 14, 2024Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THEIR NEONATAL ICU SITE HAS INCORRECT CONNECTORS FOR THE 3.5FR SINGLE LUMEN UMBILICAL CATHETERS. THE HUB HAS TWO NOTCHES THAT DO NOT CONNECT WITH THEIR SYRINGES OR TUBING. WHILE TRYING TO CONNECT THE LINE, THE PRACTITIONERS KEPT TURNING THE CATHETER BUT WERE UNABLE TO GET IT TO CONNECT PROPERLY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT UNABLE TO FULLY SECURE A BD 5 ML SYRINGE ONTO UVC LUER ¿LUGS¿. THE ISSUE OCCURRED DURING 1ST ACCESS WITH SYRINGE. THE CUSTOMER VERIFIED MANUALLY AND NOTICED THAT THREADS WERE NOT ENGAGING WITH SYRINGE LUER. THE LUER LUGS APPEARED TO BE BENT AWAY FROM LUER, WHEN COMPARED WITH COMPONENT DESIGN. THE NURSES EVALUATED THE OTHER UVC PRODUCTS FROM THE SAME LOT AND CONNECTION WITH SYRINGE SEEMED TO FUNCTION AS INTENDED. THEY WERE ABLE TO SUCCESSFULLY CONNECT A SYRINGE OR OTHER DEVICE, WITHOUT AN ISSUE. A NURSE ALSO EVALUATED ATTACHING THE EXACT 5 ML SYRINGE USED IN THE REPORTED COMPLAINT TO ONE UVC LUER FROM THE SAME LOT (NOT THE SUBJECT OF COMPLAINT) AND SAID IT CONNECTED TO THE NEW UVC ACCEPTABLY AND NO ISSUE OBSERVED. THIS INFERS THAT THE SYRINGE USED WAS NOT TO BLAME. THERE WAS NO PATIENT HARM REPOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982178 ↗
• MalfunctionAug 14, 2024Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THEIR NEONATAL ICU SITE HAS INCORRECT CONNECTORS FOR THE 3.5FR SINGLE LUMEN UMBILICAL CATHETERS. THE HUB HAS TWO NOTCHES THAT DO NOT CONNECT WITH THEIR SYRINGES OR TUBING. WHILE TRYING TO CONNECT THE LINE, THE PRACTITIONERS KEPT TURNING THE CATHETER BUT WERE UNABLE TO GET IT TO CONNECT PROPERLY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT UNABLE TO FULLY SECURE A BD 5 ML SYRINGE ONTO UVC LUER ¿LUGS¿. THE ISSUE OCCURRED DURING 1ST ACCESS WITH SYRINGE. THE CUSTOMER VERIFIED MANUALLY AND NOTICED THAT THREADS WERE NOT ENGAGING WITH SYRINGE LUER. THE LUER LUGS APPEARED TO BE BENT AWAY FROM LUER, WHEN COMPARED WITH COMPONENT DESIGN. THE NURSES EVALUATED THE OTHER UVC PRODUCTS FROM THE SAME LOT AND CONNECTION WITH SYRINGE SEEMED TO FUNCTION AS INTENDED. THEY WERE ABLE TO SUCCESSFULLY CONNECT A SYRINGE OR OTHER DEVICE, WITHOUT AN ISSUE. A NURSE ALSO EVALUATED ATTACHING THE EXACT 5 ML SYRINGE USED IN THE REPORTED COMPLAINT TO ONE UVC LUER FROM THE SAME LOT (NOT THE SUBJECT OF COMPLAINT) AND SAID IT CONNECTED TO THE NEW UVC ACCEPTABLY AND NO ISSUE OBSERVED. THIS INFERS THAT THE SYRINGE USED WAS NOT TO BLAME. THERE WAS NO PATIENT HARM REPOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982081 ↗
• MalfunctionAug 14, 2024Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THEIR NEONATAL ICU SITE HAS INCORRECT CONNECTORS FOR THE 3.5FR SINGLE LUMEN UMBILICAL CATHETERS. THE HUB HAS TWO NOTCHES THAT DO NOT CONNECT WITH THEIR SYRINGES OR TUBING. WHILE TRYING TO CONNECT THE LINE, THE PRACTITIONERS KEPT TURNING THE CATHETER BUT WERE UNABLE TO GET IT TO CONNECT PROPERLY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT UNABLE TO FULLY SECURE A BD 5 ML SYRINGE ONTO UVC LUER ¿LUGS¿. THE ISSUE OCCURRED DURING 1ST ACCESS WITH SYRINGE. THE CUSTOMER VERIFIED MANUALLY AND NOTICED THAT THREADS WERE NOT ENGAGING WITH SYRINGE LUER. THE LUER LUGS APPEARED TO BE BENT AWAY FROM LUER, WHEN COMPARED WITH COMPONENT DESIGN. THE NURSES EVALUATED THE OTHER UVC PRODUCTS FROM THE SAME LOT AND CONNECTION WITH SYRINGE SEEMED TO FUNCTION AS INTENDED. THEY WERE ABLE TO SUCCESSFULLY CONNECT A SYRINGE OR OTHER DEVICE, WITHOUT AN ISSUE. A NURSE ALSO EVALUATED ATTACHING THE EXACT 5 ML SYRINGE USED IN THE REPORTED COMPLAINT TO ONE UVC LUER FROM THE SAME LOT (NOT THE SUBJECT OF COMPLAINT) AND SAID IT CONNECTED TO THE NEW UVC ACCEPTABLY AND NO ISSUE OBSERVED. THIS INFERS THAT THE SYRINGE USED WAS NOT TO BLAME. THERE WAS NO PATIENT HARM REPOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981880 ↗
• MalfunctionJul 9, 2024Gas/Air Leak; Gas/Air Leak

  THE CUSTOMER REPORTED THAT THE ITEM FAILED DUE TO A LEAK. THEY USED 2 OF THE SAME LOT AND BOTH FAILED. THEY PROCEEDED TO USE A DIFFERENT LOT AND IT WORKED. THE NURSE REPORTED THAT LINES WERE PLACED AND WITHIN 30 MINUTES OF LINES BEING IN, THEY CLOTTED OFF AND FILLED WITH AIR. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS AIR IN THE LINE. THE DEVICE WAS REPLACED AND NO ISSUE FURTHER ISSUES OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19705721 ↗
• MalfunctionJun 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER REPORTS: THE LINE WAS LEAKING FROM THE CATHETER AND BLOOD WAS BACKING UP. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024 STATED THAT THE SKIN WAS CLEANED WITH BETADINE. THE DEVICE WAS SECURED WITH TEGADERM/SUTURE AND EACH LINE WAS FLUSHED WITH INFUSING FLUIDS USING SALINE WITH HEPARIN, AND A 3ML SYRINGE. THE PICC WAS REMOVED ON THE SAME DAY THAT IT WAS PLACED AND WAS SUBSEQUENTLY REPLACED WITH THE SAME TYPE OF CATHETER. THE PATIENT IS 6/7 WEEKS. THERE WAS NO SIGNIFICANT BLOOD LOSS OR SIGNS OF DISTRESS OR COMPLICATIONS. THE CURRENT STATUS OF THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567705 ↗
• MalfunctionMar 19, 2024Break; Break

  THE CUSTOMER REPORTED THAT ON (B)(6) 2024 A 3.5 FR UMBILICAL CATHETER WAS PLACED BY STERILE TECHNIQUE IN AN UMBILICAL ARTERY AND SUTURED IN PLACE. THE CATHETER WAS INSERTED UP TO THE 13CM MARK. ON (B)(6) 2024 THE CATHETER WAS REMOVED BY THE BEDSIDE RN, SUTURES REMOVED PRIOR TO REMOVAL. DURING REMOVAL, THE CATHETER HAD A CLEAN BREAK AT APPROXIMATELY THE 9.25 CM MARK. THE RN HAD A STERILE HEMOSTAT AVAILABLE AND WAS ABLE TO ATTACH TO THE REMAINING CATHETER AND REMOVE THE REMAINDER FROM THE UMBILICUS. NO HARM WAS DONE. THE RN REPORTED THE REMOVAL PROCESS WENT SMOOTHLY PRIOR TO THE BREAK, NO INCREASE IN TENSION WHEN REMOVING THE LINE. ON 11MAR2024 THE INITIAL REPORTER STATED THAT THE CATHETER BROKE INTO TWO SEPARATE PIECES WHICH THE NURSE WAS ABLE TO SEE AT ALL TIMES DURING THE TIME IT WAS BROKEN THEN REMOVED. THE RN REPORTED THE REMOVAL WAS THE SAME AS FAR AS THE REMOVAL OF OTHER UMBILICAL LINES. NO FURTHER TREATMENT REQUIRED. THE CUSTOMER CONFIRMED IT WAS A STANDARD REMOVAL DUE TO THE ORDER TO DISCONTINUE THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937249 ↗
• MalfunctionOct 5, 2023Break; Break

  THE CUSTOMER REPORTED THAT 10 CM OF THE 3.5FR CATHETER WAS LEFT IN THE BODY WHEN THE PHYSICIAN EXTRACTED THE CATHETER. THERE WERE NO ADVERSE REACTIONS REPORTED. PER ADDITIONAL INFORMATION RECEIVED, INFORMATION ABOUT HOW THE CATHETER PART WAS LEFT IN THE BODY, IF ALL PIECES WERE RETRIEVED AND MEDICAL INTERVENTION REQUIRED IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17876328 ↗
• InjuryAug 2, 2023Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE UVC WAS SEEN TO BE MALPOSITIONED ON KUB. THE UMBILICAL AREA WAS CLEANED AND PREPPED WITH BETADINE. A TIME OUT WAS PERFORMED AT 6PM. THE LINE WAS REMOVED 2CM TO 6CM. ON REPEAT KUB THE CATHETER STILL APPEARED MALPOSITIONED. UPON A SECOND ATTEMPT TO FURTHER ADJUST THE LINE SEPARATED FROM ITSELF. IT SEPARATED AT APPROX. 4.5CM MARK. THE RETAINED PIECE WAS UNABLE TO BE VISUALIZED AT THE STUMP. A KUB WAS OBTAINED, REVEALING A PIECE OF CATHETER. DR. (B)(6) AND THE NICU FELLOW WERE NOTIFIED. DR. (B)(6) CALLED THE INTERVENTIONAL CARDIOLOGY ATTENDING, THE PEDIATRIC SURGICAL ATTENDING AND THE CARDIAC ANESTHESIA ATTENDING. DR.(B)(6) ALSO SPOKE IN PERSON TO THE PARENTS. ADDITIONAL INFORMATION RECEIVED ON 02AUG2023 STATED THAT THE UVC WAS FIRST PLACED ON (B)(6) 2023. THE RETAINED PIECE WAS IN THE UMBILICAL VEIN. THEY REMOVED THE RETAINED PIECE BY DILATION OF UMBILICAL VEIN, SURGICAL METHOD IN THE OR. THE INFANT REQUIRED INTUBATION FOR THE PROCEDURE. THEY STATED IT WAS "HOURS" BETWEEN NOTICING THE SEPARATION AND REMOVING THE PIECE. THERE WAS NO INJURY OR HARM TO THE PATIENT DUE TO THIS INCIDENT. THE CATHETER WAS NOT CURLED INSIDE THE PATIENT. THE PATIENT'S WEIGHT: 1.

  Patient problems: Foreign Body In Patient

  MAUDE report 17447281 ↗
• InjuryMar 30, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE PRODUCT BROKE DURING USE. PER ADDITIONAL INFORMATION RECEIVED, THE PROCEDURE BEING PERFORMED WAS A UVC REMOVAL. THE CATHETER SNAPPED/BROKE INTO 2 PIECES. THE DOCTOR WAS ABLE TO GRAB THE REMAINDER OF THE LINE THAT WAS STILL IN SITU WITH FORCEPS. SCANT BLOOD LOSS WAS NOTED FROM THE LINE. THE DOCTOR WAS ABLE TO APPLY A CLAMP AND COMPLETE REMOVAL OF THE REMAINING LINE. THE TIP WAS INTACT UPON REMOVAL. THE UVC WAS IN SITU AT 6CM AND THE LINE APPEARED TO HAVE BROKEN BETWEEN THE 5CM AND 6CM MARKING, JUST ABOVE WHERE THE LINE WAS SUTURED. NO FURTHER BLEEDING WAS NOTED FROM THE SITE ONCE THE LINE WAS FULLY REMOVED. THERE WAS A SLIGHT DELAY IN THE PROCEDURE. THERE WAS NO MEDICATION ADMINISTERED. THERE WAS NO INJURY OR ADVERSE EVENT REPORTED.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16643088 ↗
• MalfunctionNov 4, 2022Break; Break

  ADDITIONAL INFORMATION RECEIVED FEBRUARY 1, 2023: THE CUSTOMER CLARIFIED THAT THE CATHETER DID NOT BREAK WHEN BEING REMOVED, IT WAS REMOVED BECAUSE IT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15724209 ↗