MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PERITONEAL DIALYSIS CATHETER.ARC

Catalog Number	CF-5450/C
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Codes	Bacterial Infection (1735); Peritonitis (2252)
Date of Event	02/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is still in use but expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a dialysis procedure, the peritoneal dialysis catheter tubing was found to have a small pinhole in the end.The medical staff cut 5.5cm from the exit point on the catheter to remove the hole.The procedure progressed normally.An infection "peritonitis" was identified and the patient received antibiotics/medical intervention.The patient is still using the pd catheter today.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually.The complaint is confirmed.No definitive root cause could be determined however, it was found the device expired september 2019.Extended use of the device or possible use of expired product may have contributed to the wear on the catheter tubing.A small hole was also identified on the tubing indicating that the hole in the tubing may have been caused by friction.A search of the complaint database found no similar complaints for this lot number from the same customer.The device history record was reviewed, and no exception documents were found.

• Brand Name: PERITONEAL DIALYSIS CATHETER.ARC
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 11592455
• Report Number: 1721504-2021-00021
• Device Sequence Number: 4108398
• Product Code: DRE
• UDI-Device Identifier: 00884450330203
• UDI-Public: 884450330203
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K070730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

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: 09/30/2019
• Device Catalogue Number: CF-5450/C
• Device Lot Number: H1224495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 06/06/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 06/09/2021
• 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: Hospitalization; Required Intervention