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

Model Number	00884450330067
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that the tubing of a pediatric peritoneal dialysis catheter broke after the tubing was disconnected with a plastic clamp.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The device was examined visually, the break found in the tubing appeared to be rigid ,the catheter was not cut.The freka schlauchkelemme weiss clamp is not qualified to be used on the pd catheter and not ifu recommended.The ifu states "if necessary, use clip included in kit to clamp the catheter to control the flow of saline".The catheter had also been in the patient for over three years.The age of the catheter and the clamp most likely caused some wear/damage to the integrity of the tubing and then broke when under pressure.The customer's complaint is confirmed.The root cause is attributed to using an unqualified clamp on the tubing and the age of the catheter.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: FLEX NECK PERITONEAL DIALYSIS CATHETER
• Common Device Name: PERITONEAL DIALYSIS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 10680962
• Report Number: 1721504-2020-00085
• Device Sequence Number: 3094538
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2020

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: 06/30/2020
• Device Model Number: 00884450330067
• Device Catalogue Number: CF-4230/C
• Device Lot Number: H1217444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 11/22/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 12/03/2020
• 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: Required Intervention
• Patient Age: 3 YR