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

Model Number	8888413401
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2017
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 the catheter was found to be disconnected inside the patient during a ct scan.The catheter was replaced and there was no consequence to the patient.
Additional Manufacturer Narrative
A device history record (dhr) review was performed and no discrepancies that may have contributed to a complaint of this nature were found.The quality inspection of final visual and physical evaluation results indicated that the product met specification requirements.The sample consisted of one peritoneal dialysis (pd) catheter which came inside a plastic bag with an adapter and clamp.The sample presented signs of use.Visual inspection was performed, and it was observed that the catheter was cut in two parts.Additionally, the cuffs were firmly adhered to the catheter.An ishikawa diagram was used to determine the potential causes for this event and the manufacturing process for this product was reviewed.During evaluation, it was observed that the manufacturing steps and activities are appropriate, and the applicable procedures are clear enough and contain controls to prevent a deviation.The reported condition has been confirmed.Based on all gathered information, the probable root cause for this event cannot be determined.No trends or triggers have been found for this 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: 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: 6756679
• Report Number: 3009211636-2017-05243
• Device Sequence Number: 877709
• Product Code: FJS
• UDI-Device Identifier: 10884521004597
• UDI-Public: 10884521004597
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 11/27/2017

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: 07/28/2020
• Device Model Number: 8888413401
• Device Catalogue Number: 8888413401
• Device Lot Number: 1523800143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 08/01/2017
• Supplement Report FDA Received Date: 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1