MAUDE Adverse Event Report: TELEFLEX MEDICAL TAUT INTRADUCER

Model Number PI-93

Device Problem Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 05/05/2014

Event Type  malfunction  

Event Description

A taut intraducer catheter was used for the purpose of performing cholangiograms intraoperatively.The trocar was introduced into the abdomen, the inner needle removed and catheter inserted into the sleeve.While performing the case, a small disc like object was noted in the surgical field.The object was retrieved without incident.A new taut intraducer catheter was opened to compare to the one on the field.It was noted that the clear reducer membrane on the top was missing on the used catheter and was in fact the piece removed from the abdomen.

• Brand Name: TAUT INTRADUCER
• Type of Device: TAUT INTRADUCER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC 27709
• MDR Report Key: 3835718
• MDR Text Key: 4501993
• Report Number: MW5036276
• Device Sequence Number: 1
• Product Code: GCA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: PI-93
• Device Lot Number: 01B1400566
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 74