MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PERITONEAL DIALYSIS CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number	00884450330067
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
Event or Problem Description
The account alleges that after successful implant the pd catheter started showing signs of fatigue.Micro-cracks appeared at the hub end of the catheter, outside patient body.Liquid was noted leaking from the catheter.The hose has been shortened by medical professionals 3 times thus removing the cracked tubing.

• Brand Name: PERITONEAL DIALYSIS CATHETER
• Common Device Name: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 12478338
• Report Number: 1721504-2021-00065
• Device Sequence Number: 4264518
• Product Code: FJS
• UDI-Device Identifier: 00884450330067
• UDI-Public: 00884450330067
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K031351
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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 Model Number: 00884450330067
• Device Catalogue Number: CF-4230
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1