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

Model Number	8888541028P
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
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, during use, it was noted that the blue (venous) luer adapter had hairline cracks and had a leak.It was stated that the catheter was initially repaired with a repair kit, no instrument was used to loosen or tighten the device, alcohol-free were used as cleaning agents.It was also stated that cleaning agents are allowed to dry thoroughly prior to applying ointments on the area, prior to dressing the area, and patients are not responsible for any type of catheter maintenance, cleaning agents were not switched over the lie of the catheter, cleaning agents were not mixed and the same cleaning agents are always used.Treatment continues with the repaired catheter and the damaged/cracked luer adapters were discarded.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: 8231756
• Report Number: 3009211636-2019-00008
• Device Sequence Number: 16549461
• Product Code: MSD
• UDI-Device Identifier: 10884521158511
• UDI-Public: 10884521158511
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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: 05/31/2021
• Device Model Number: 8888541028P
• Device Catalogue Number: 8888541028P
• Device Lot Number: 1731900150
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 01/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 60