MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PERITONEAL; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number	8888413807
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, it was observed on the computed tomography (ct) that the catheter had broken into two inside the patient.The peritoneal dialysis (pd) catheter was removed.A surgical procedure was done for the retrieval of the catheter and a new one was implanted.The catheter was placed 2 years prior.The patient has recovered.
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 physical sample involved in the reported incident was not returned for evaluation.Three photos were provided by the customer.Visual evaluation of these photos was performed.The three pictures showed a catheter inside a plastic container.In these photos were observed that the catheter was split in two parts.The images reveal that the device showed signs of use (possibly remains of blood).The reported condition has been confirmed.Based on evaluation the catheter showed on the device a split or cut.According the available information there is enough evidence to manufacturing process discarded.The most probable root cause could be related to a misuse, since the defect was found during use.Based on pictures provided, this issue could be caused by an improper technique of sharp objects or cleaning agents.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.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted that the device was received in three (3) pieces.Pmv performed functional testing which included submerging the catheter into a water bath.The end was clamped, and a syringe was used to inject air to observe leakage.No air bubbles were present.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Replication of the cut in the circular seal may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PERITONEAL
• Common Device Name: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7440755
• Report Number: 3009211636-2018-00119
• Device Sequence Number: 1147239
• Product Code: FJS
• UDI-Device Identifier: 10884521004610
• UDI-Public: 10884521004610
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K862046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2019
• Device Model Number: 8888413807
• Device Catalogue Number: 8888413807
• Device Lot Number: 1434900108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Initial Date Received by Manufacturer: 12/05/2017
• Supplement Date Received by Manufacturer: 05/23/2018; 08/24/2018
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 06/22/2018; 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention