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

Model Number	8888411702
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer states during insertion of the catheter into the patient the second cuff was detached.There was no harm to the patient.
Additional Manufacturer Narrative
(b)(6).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.Three photos were provided by the customer.Visual evaluation of these photos was performed.The first and second pictures show that the customer put the cuff in the interior of a syringe.In these photos, it can only be observed that the cuff has remains of blood.The last image is of the label of a box of the peritoneal dialysis catheter.With the pictures provided nothing more could be determined about the device.Additionally, a sample was received for analysis and investigation.The sample consisted of a syringe, a cuff, and a piece of the carton with part of the label for the catheter.Visual inspection was performed, and it was observed there was one cuff inside the syringe.This cuff was detached from the catheter and the catheter was not returned as part of the sample evaluation.The cuff presented signs of use.The risk files were reviewed, and an ishikawa diagram was used to determine the potential causes for this event.The instructions for use (ifu) indicate not to use excessive force when inserting the catheter because the catheter tubing can tear when subjected to excessive force or rough edges.100% visual inspection for necking of the tubing, nicks, cuts or blemishes that do not meet drawing specifications is performed by manufacturing according to the procedure.The reported condition has been confirmed.Based on all gathered information, the most probable root cause for this event can be considered as excessive force when inserting the catheter.No complaint trends or triggers were identified.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: PERITONEAL
• Common Device Name: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 0101
• MDR Report Key: 6851527
• Report Number: 3009211636-2017-05287
• Device Sequence Number: 16249034
• Product Code: FJS
• UDI-Device Identifier: 10884521004337
• UDI-Public: 10884521004337
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

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: 05/02/2020
• Device Model Number: 8888411702
• Device Catalogue Number: 8888411702
• Device Lot Number: 1514800162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 12/12/2017
• Initial Report FDA Received Date: 09/08/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1