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

Model Number	8888145044P
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED, COATED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8453818
• Report Number: 3009211636-2019-00068
• Device Sequence Number: 10818511
• Product Code: NYU
• UDI-Device Identifier: 20884521158099
• UDI-Public: 20884521158099
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 71