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

Model Number	00884450170298
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) infant with a history of end-stage renal disease.He has undergone hemodialysis and his primary nephrologist requested a peritoneal dialysis catheter to be inserted for long-term renal replacement therapy.When the peritoneal dialysis catheter 2 cuffs pediatric coiled package was opened in preparation for insertion, it was discovered the package did not contain the right peritoneal catheter.Several other packages opened with same results.The distal cuff to coil length was longer than what was indicated on the packaging.Surgeon had to place an infant sized catheter.Per surgeon, the catheter enclosed in the package was too big for the patient, and the measurements indicated on the packaging did not match the catheter enclosed.All peritoneal catheters of all sizes (infant, pediatric, adolescent, adult small and adult regular) pulled from stock.There is a concern this infant catheter may not work properly for the patient as it had been requested to try to avoid the neonatal size because of smaller diameter to allow for better lumen.The pd catheter the patient previously had before hemodialysis was neonatal and per nephrologist was a struggle because of the lumen.Patient has had one brief dialysis treatment without any issues.

• Brand Name: FLEX-NECK
• Common Device Name: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 west merit parkway; south jordan UT 84095
• MDR Report Key: 7082126
• Report Number: 7082126
• Device Sequence Number: 1130586
• Product Code: FJS
• UDI-Device Identifier: 10884450170295
• UDI-Public: (01)10884450170295(17)190131(10)H1063581
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 12/01/2017
• Report Date (Section F): 12/01/2017

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: No Information
• Device Expiration Date: 01/31/2019
• Device Model Number: 00884450170298
• Device Catalogue Number: CF-5242
• Device Lot Number: H1063581
• Other Device ID Number: H1082840
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 4
• Date Report Sent to FDA: 12/01/2017