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

Model Number PI-104

Device Problem Fitting Problem (2183)

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

Event Date 10/21/2022

Event Type  malfunction  

Event Description

The taut intraducer was defective.The two pieces do not fit together.We tried two packages with the same problem.The lot number was the same for both packages.The procedure proceeded with no further complications.(b)(4).Fda safety report id # (b)(4).

• Brand Name: TAUT INTRADUCER
• Type of Device: CATHETER, PERITONEAL
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 15789354
• MDR Text Key: 303704782
• Report Number: MW5113225
• Device Sequence Number: 1
• 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: 11/09/2022
• 2 Devices were Involved in the Event: 1 2

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: PI-104
• Device Lot Number: 73A2200668
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR