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

Model Number	8888145069
Medical Device Problem Codes	Material Puncture/Hole (1504); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of two photos of a device.A visual inspection of the returned photos noted: the first photo depicts the catheters white protective covering near the red luer lock ¿ arterial lumen to be cut.The second photo depicts the same.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the cut in the protective covering near the lumen may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.No further actions have been deemed necessary at this time.Based on the evidence available the reported condition was confirmed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use, when facility employed a "scrub to the hub" cleaning technique before each treatment, they noticed that the catheters' white "tape" on either the venous and arterial ends are either deteriorating or being ripped/cut.It was stated that there was leak at the venous blue end.There was no reported blood loss, and no intervention was required.Chlorohexidine gluconate was the cleaning agent used.There was no reported patient injury.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8271577
• Report Number: 3009211636-2019-00012
• Device Sequence Number: 16172267
• Product Code: MSD
• UDI-Device Identifier: 10884521056701
• UDI-Public: 10884521056701
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2019

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: 11/22/2017
• Device Model Number: 8888145069
• Device Catalogue Number: 8888145069
• Device Lot Number: 1435600095
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2018
• Initial Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1