MAUDE Adverse Event Report: TELEFLEX MEDICAL PERITONEAL TAUT CATHETER INTRADUCER; CATHETER, PERITONEAL

Model Number REF-PI-104

Device Problem Failure to Advance (2524)

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

Event Date 08/26/2022

Event Type  malfunction  

Event Description

Peritoneal tut catheter intraducer unable to pass through catheter for grams.The issue was observed on the back table prior to reaching the patient x 5 cases.A 14 gauge angiocath was used instead x 4 cases.On the 5th case, a different lot number of taut catheter intraducer was opened and worked appropriately.All taut catheter intraducers with lot #73a2200781 removed from shelf central supply notified.Item: taut intraducer peritoneal catheter.Ref: pi-104.Lot number: 73a2200781.Exp: 01/24/2025.

• Brand Name: PERITONEAL TAUT CATHETER INTRADUCER
• Type of Device: CATHETER, PERITONEAL
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd.; morrisville NC
• MDR Report Key: 15470696
• MDR Text Key: 300649847
• Report Number: MW5112227
• Device Sequence Number: 2
• Product Code: GBW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/29/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REF-PI-104
• Device Lot Number: 73A2200781
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2022
• Patient Sequence Number: 1
• Patient Sex: Male