MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 15FX57.5CM CURLED PD W/2 CUFFS; CURLED PERITONEAL DIALYSIS CATHETER W/2 CUFFS

Model Number MDC57C

Device Problem Separation Problem (4043)

Patient Problem Peritonitis (2252)

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient developed peritonitis following 2 x accidental disconnection of pd catheter extension.Pd peritonitis requiring admission and antibiotics.

Manufacturer Narrative

No device was returned and no photographs were provided.The contract manufacturer conducted a review of the manufacture records for the lot number reported.The review showed the device was manufactured according to specification with no non-conformances or abnormalities.Without an evaluation of the device a definitive root cause cannot be determined.Medcomp does not manufacture the extension sets that disconnected from the catheter luer.It is possible that the mating ends of the extension sets were not within specification and may have been a contributing factor to the failure.Device was used for treatment, not diagnosis.

Event Description

It was confirmed the female luer disconnected from the extension tubing.

• Brand Name: 15FX57.5CM CURLED PD W/2 CUFFS
• Type of Device: CURLED PERITONEAL DIALYSIS CATHETER W/2 CUFFS
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10670982
• MDR Text Key: 211269074
• Report Number: 2518902-2020-00047
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 00884908030068
• UDI-Public: 884908030068
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MDC57C
• Device Catalogue Number: MDC57C
• Device Lot Number: MNRF590
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention