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

Model Number	8888145058
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2017
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
The customer stated the venous luer adapter was leaking and could not be separated from the cap.A crack was observed and the catheter was repaired.There was no harm to the patient.
Additional Manufacturer Narrative
Additional information photo evaluation: a device history record (dhr) 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.In addition, all dhrs are reviewed for accuracy prior to product release.The physical sample involved in the reported incident was not returned for evaluation.One photo was provided by the customer.Visual evaluation of this photo was performed.The picture showed a venous adapter over a surface.In this photo it was observed that the thread of the adapter was broken in two parts and one of parts had a cap attached.Additionally, this image revealed that the device showed signs of use.Manufacturing performs 100% inspection for cracked adapters per procedure which would identify this issue in the catheter assembly.An ishikawa diagram was used to determine the potential causes for this event.The instructions for use (ifu) state that the customer should perform an inspection before using the device and that over tightening t he catheter connections can crack some adapters.The reported condition has 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.The adapter was most likely damaged due to manipulation and the most possible root cause can be considered as the instructions for use were not followed causing adapter over tightening.No trends or triggers have been found for this particularly event, therefore, a corrective and preventive action (capa) is not 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: 7118024
• Report Number: 3009211636-2017-05396
• Device Sequence Number: 1450914
• Product Code: MSD
• UDI-Device Identifier: 10884521013339
• UDI-Public: 10884521013339
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018

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: 11/09/2021
• Device Model Number: 8888145058
• Device Catalogue Number: 8888145058
• Device Lot Number: 1634300190
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1