Cook TPN G04261Recalls & reported problems
Cook Incorporated · Cook TPN, Single Lumen Catheter · Class 2 · Implant
All models of Cook TPN (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Cook TPN single lumen catheter is a short-term intravascular catheter. The 30 reports describe the line breaking, snapping at the point where the thick and thin sections meet, developing small holes, and the inner and outer layers separating, with several noting trouble working with the repair kit. No deaths or injuries were reported, and 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
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00827002042612), received between Sep 12, 2017 and Sep 25, 2017 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Break” (18 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
Device problems
- Break18
- Device Operates Differently Than Expected3
- Hole In Material3
- Material Separation3
- Material Twisted/Bent3
- Detachment Of Device Component2
- Difficult to Insert2
- Loose or Intermittent Connection2
Patient problems
- No Known Impact Or Consequence To Patient27
- No Information2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2017Break
THE COMPLAINANT REPORTED THAT THE LINE BROKE AND COULD NOT BE REPAIRED. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6891841 ↗MalfunctionSep 25, 2017Break
IT WAS REPORTED THE PICC LINE SNAPPED WHERE THICK MEETS THIN. THERE WERE NO ISSUES WITH THE REPAIR OF THE DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6890865 ↗MalfunctionSep 25, 2017Hole In Material
IT WAS REPORTED THERE WAS A HOLE IN THE PICC LINE. IT WAS ALSO REPORTED THAT REPAIR CHALLENGES WERE ENCOUNTERED: DIFFICULT REPAIR.
Patient problems: No Information
MAUDE report 6890815 ↗MalfunctionSep 25, 2017Break
IT WAS REPORTED THE PICC LINE SNAPPED AT HOME. THERE WERE NO DETAILS GIVEN REGARDING REPAIR CHALLENGES.
Patient problems: No Information
MAUDE report 6890793 ↗MalfunctionSep 25, 2017Material Separation
IT WAS REPORTED THE OUTER LUMEN OF THE PICC LINE SEPARATED FROM INNER WHERE THICK MEETS THIN. IT WAS ALSO REPORTED THAT REPAIR CHALLENGES WERE ENCOUNTERED: SLEEVE TIGHT ON REPAIR KIT, WAS SLOWLY ABLE TO WIGGLE IT OFF WITHOUT DAMAGING REPAIR, OTHERWISE NO ISSUES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6890757 ↗MalfunctionSep 25, 2017Hole In Material; Failure to Advance
IT WAS REPORTED THERE WAS A SMALL HOLE IN THE PICC LINE JUST BELOW WHERE THICK MEETS THIN. IT WAS ALSO REPORTED THAT REPAIR CHALLENGES WERE ENCOUNTERED: USED 2 KITS AS FIRST KIT DID NOT LET GUIDE WIRE THROUGH, BUNCHING WHEN ATTACHING REPAIR KIT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6890617 ↗MalfunctionSep 25, 2017Device Operates Differently Than Expected
IT WAS REPORTED THAT THE LINE REQUIRED REPAIRS, BUT NO FURTHER INFORMATION IS KNOWN. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6890125 ↗MalfunctionSep 25, 2017Device Operates Differently Than Expected
IT WAS REPORTED THAT THE LINE NEEDED TO BE REPAIRED, THOUGH NO OTHER DETAILS ARE AVAILABLE. THERE WERE NO PATIENT INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6890108 ↗MalfunctionSep 22, 2017Hole In Material
IT WAS REPORTED THERE WAS A HOLE IN THE PICC LINE AND BULGING CLOSE TO THE EXIT SITE. IT WAS ALSO REPORTED THAT THE DEVICE WAS DIFFICULT TO REPAIR. THERE WERE NO INJURIES OR ADDITIONAL MEDICAL INTERVENTION REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6887863 ↗MalfunctionSep 22, 2017Partial Blockage
IT WAS REPORTED THE PICC LINE WAS BLOCKED AND BECAME WET WHEN FLUSHED, SO IT LIKELY HAD A HOLE. THERE WERE NO ISSUES ENCOUNTERED WITH REPAIR OF THE LINE. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6887858 ↗MalfunctionSep 22, 2017Detachment Of Device Component; Loose or Intermittent Connection; Material Twisted/Bent
IT WAS REPORTED THAT THE AREA OF THE PICC LINE WHERE THE LUER ATTACHES TO THE LINE WAS LOOSE AND TWISTED AROUND. IT WAS ALSO REPORTED THAT WHEN FLUSHED, THE LUER BLEW OFF. THERE WERE NO ISSUES WITH THE REPAIR OF THE LINE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6887817 ↗MalfunctionSep 15, 2017Break
THE COMPLAINANT REPORTED THAT THE LINE OF THE SINGLE LUMEN TPN CATHETER SNAPPED AT HOME. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6869768 ↗MalfunctionSep 15, 2017Break; Detachment Of Device Component
THE COMPLAINANT REPORTED THAT THE SINGLE LUMEN CATHETER TPN LINE SNAPPED AT HOME AND IT WAS REPAIRED WITH MINIMAL DIFFICULTY. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6869756 ↗MalfunctionSep 14, 2017Break; Difficult to Insert; Device Inoperable
THE COMPLAINANT REPORTED THAT THE LINE "BROKE WHERE THICK MEETS THIN" AND 2 REPAIR KITS WERE USED. THE 1ST REPAIR KIT WOULD NOT WORK AS THE GUIDE WIRE WOULD NOT PASS THROUGH CATHETER. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THE PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6864751 ↗MalfunctionSep 14, 2017Break
THE COMPLAINANT REPORTED THAT THE LINE "BROKE WHERE THICK MEETS THIN." NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6864712 ↗MalfunctionSep 14, 2017Material Separation
THE COMPLAINANT REPORTED THAT THE OUTER LUMEN SEPARATED FROM INNER LUMEN. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6864679 ↗MalfunctionSep 14, 2017Break
THE COMPLAINANT REPORTED THAT THE LINE "BROKE WHERE THICK MEETS THIN", A REPAIR KIT WAS USED. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6864656 ↗MalfunctionSep 14, 2017Break; Folded
THE COMPLAINANT REPORTED THAT THE LINE "SNAPPED WHERE THICK MEETS THIN." THEY ATTEMPTED TO REPAIR THE DEVICE WITH THE REPAIR KIT AND THERE WAS "LOTS OF BUNCHING." MULTIPLE CUTS WERE MADE AS THE INNER LUMEN KEPT BUNCHING AND WOULDN¿T LET THE REPAIR THROUGH. THE MULTIPLE CUTS MADE THE REPAIRABLE AREA VERY SHORT. THE REPAIR WAS UNSUCCESSFUL AND THE 2ND IV NURSE EXPERIENCED THE SAME ISSUES WITH THE REPAIR. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6864638 ↗MalfunctionSep 14, 2017Break; Material Twisted/Bent
THE COMPLAINANT REPORTED THAT THE LINE "SNAPPED WHERE THICK MEETS THIN." THEY ATTEMPTED TO REPAIR THE DEVICE WITH THE REPAIR KIT AND THERE WAS "LOTS OF BUNCHING." MULTIPLE CUTS WERE MADE AS THE INNER LUMEN KEPT BUNCHING AND WOULDN'T LET THE REPAIR THROUGH. THE MULTIPLE CUTS MADE THE REPAIRABLE AREA VERY SHORT. THE REPAIR WAS UNSUCCESSFUL ON THIS DAY AND THE 2ND IV NURSE EXPERIENCED THE SAME ISSUES WITH THE REPAIR. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6864626 ↗MalfunctionSep 14, 2017Material Separation
THE COMPLAINANT REPORTED THAT THE LINE "SEPARATED FROM WHERE THICK MEETS THIN" AND WAS REPAIRED WITH A REPAIR KIT. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6864624 ↗MalfunctionSep 14, 2017Break
THE COMPLAINANT REPORTED THAT THE LINE "BROKE WHERE THICK MEETS THIN." IT WAS ALSO REPORTED THAT THE REPAIR WAS "DIFFICULT" AND A "VERY SHORT AMOUNT LEFT TO TRY TO PUT REPAIR KIT ONTO." THE REPAIR KEPT BOUNCING OUT AND WOULDN¿T STAY IN PLACE SO IT TOOK LONGER THAN USUAL TO REPAIR. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THE PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6864597 ↗MalfunctionSep 14, 2017Break
THE COMPLAINANT REPORTED THAT THE LINE "BROKE WHERE THICK MEETS THIN", THERE WERE NOT ISSUES WITH THE REPAIR. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6864570 ↗MalfunctionSep 14, 2017Break
THE COMPLAINANT REPORTED THAT THE LINE "SNAPPED WHERE THICK MEETS THIN." THE THICK PART OF LINE WAS NOT COVERED WITH DRESSING. THE REPAIR ITSELF WAS EASY, BUT IT WAS DIFFICULT TO REMOVE THE SLEEVE OFF OF THE REPAIR AND IT WAS PARTIALLY TORN. THIS WAS NOT NOTED UNTIL AFTER THE REPAIR KIT WAS ON. THEY TRIED TO PUT THE 2ND SPLINT ON THE TORN AREA, BUT IT DIDN¿T WORK SO ANOTHER REPAIR WAS DONE 2 DAYS LATER AND 2 KITS WERE USED. IT WAS DIFFICULT AS THE INNER LUMEN KEPT BUNCHING, BUT IT FINALLY WORKED. NO ADVERSE AFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THE PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6864547 ↗MalfunctionSep 14, 2017Break; Difficult to Remove; Torn Material
THE COMPLAINANT REPORTED THAT THE LINE "SNAPPED WHERE THICK MEETS THIN." THE THICK PART OF LINE WAS NOT COVERED WITH DRESSING. THE REPAIR ITSELF WAS EASY, BUT IT WAS DIFFICULT TO REMOVE THE SLEEVE OFF OF THE REPAIR AND IT WAS PARTIALLY TORN. THIS WAS NOT NOTED UNTIL AFTER THE REPAIR KIT WAS ON. THEY TRIED TO PUT THE 2ND SPLINT ON THE TORN AREA, BUT IT DIDN¿T WORK SO ANOTHER REPAIR WAS DONE 2 DAYS LATER AND 2 KITS WERE USED. IT WAS DIFFICULT AS THE INNER LUMEN KEPT BUNCHING, BUT IT FINALLY WORKED. NO ADVERSE AFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THE PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6864512 ↗MalfunctionSep 14, 2017Break; Material Twisted/Bent
THE COMPLAINANT REPORTED THAT THE LINE "BROKE WHERE THICK MEETS THIN." THEY ATTEMPTED TO REPAIR THE DEVICE AND THE SLEEVE WAS EASY TO REMOVE, BUT THERE WAS SLIGHT BUNCHING WITH GUIDE WIRE. THE LINE WAS CUT A COUPLE OF TIMES AS THE INNER LUMEN WAS TOO BUNCHED TO ATTACH THE NEW REPAIR KIT. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6864511 ↗
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page