MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED, COATED

Model Number 8888145044P

Device Problem Material Puncture/Hole (1504)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, when checking for the impermeability of the catheter, blood was leaking at the distal junction between the red tip and the clear (white) tubing.The catheter was repaired using a repair kit in order to resolve the issue.It was also reported that hemoculture was done and was given antibiotics at the end of treatment closing both lines with antibiotic (antibiotic lock).There was no reported patient outcome.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, when checking for impermeability of the catheter, blood was leaking at the distal junction between the red tip and the clear (white) tubing.Catheter was repaired using a repair kit in order to resolve the issue.Chlorexidine swabs were used as cleaning agent.There was no noted amount of blood leak (ml).It was also reported that hemoculture was done and was given antibiotics at end of treatment closing both lines with antibiotic (antibiotic lock).There was reported patient injury.

• Brand Name: PALINDROME
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED, COATED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8453818
• MDR Text Key: 139978754
• Report Number: 3009211636-2019-00068
• Device Sequence Number: 1
• Product Code: NYU
• UDI-Device Identifier: 20884521158099
• UDI-Public: 20884521158099
• Combination Product (y/n): N
• PMA/PMN Number: K123196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2019
• Device Model Number: 8888145044P
• Device Catalogue Number: 8888145044P
• Device Lot Number: 1628800104
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/26/2019
• Supplement Dates Manufacturer Received: 03/27/2019
• Supplement Dates FDA Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 71