MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PD CATHETER INFANT CLASSIC COILED 1-CUFF PERITONEAL DIALYSIS CATHETER; CATHETER, PERITONEAL

Catalog Number CF-4253

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2020

Event Type  Injury  

Event Description

Peritoneal dialysis drain/product broke when removing at bedside.Required intervention to confirm no product left in patient.Fda safety report id# (b)(4).

• Brand Name: PD CATHETER INFANT CLASSIC COILED 1-CUFF PERITONEAL DIALYSIS CATHETER
• Type of Device: CATHETER, PERITONEAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC. ; south jordan UT 84095
• MDR Report Key: 10712020
• MDR Text Key: 212523761
• Report Number: MW5097346
• Device Sequence Number: 1
• Product Code: GBW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2022
• Device Catalogue Number: CF-4253
• Device Lot Number: H1698517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 MO