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

Model Number	8888145044
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2018
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, post- operatively, there was a leak and a crack was observed in the red (arterial) luer adapter.There was no harm to the patient.
Additional Manufacturer Narrative
Evaluation summary: a device history review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.All dhr are reviewed for accuracy prior to product release.The sample received at cms was a catheter without the arterial (red) adapter.The catheter came inside a generic plastic bag and presents a sign of manipulation the red adapter was detached from the extension and it was not presented in sample returned.The venous (blue) adapter did not present any problem.Manufacturing performed 100% inspection for cracked adapters which would identify this issue in the catheter assembly.The reported condition has not been confirmed.The evidence provided is not enough to relate this event to the manufacturing operations.Based on the available information, it can be concluded that product was manufactured according to specifications; for this reason the adapter was more likely damaged due to manipulation.The most possible root cause can be considered as misuse: the instructions for use(ifu) were not followed causing adapter over tightening.No trends or triggers have been found.No action is deemed necessary at this time.It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• 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: 7201791
• Report Number: 3009211636-2018-00020
• Device Sequence Number: 11134418
• Product Code: MSD
• UDI-Device Identifier: 20884521013244
• UDI-Public: 20884521013244
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2018

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: 07/07/2018
• Device Model Number: 8888145044
• Device Catalogue Number: 8888145044
• Device Lot Number: 1521000162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Initial Date Received by Manufacturer: 01/04/2018
• Supplement Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1