MAUDE Adverse Event Report: TELEFLEX TAUT INTRODUCER 7.5FR X 3.5; CHOLANGIOGGRAM CATHETER

Model Number PI-93

Device Problems Detachment Of Device Component (1104); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2014

Event Type  malfunction  

Event Description

Alleged event: per maude report dated (b)(6) 2014: a taut introducer catheter was used for an intra-operative cholangiogram.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 introducer 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.No reported pt injury.

Manufacturer Narrative

The device history record review (dhr) of the product taut introducers 10/bx7.5 fr x 3.5, lot # 01b1400566 was manufactured on 03/03/2014, a total of (b)(4) pieces.Lot was released on 03/06/2014.Dhr investigation did not show issues related to complaint.The complaint cannot be confirmed due to lack of a product sample to perform a proper investigation and determine the root cause.The mfr will continue to monitor and trend related complaints.

• Brand Name: TAUT INTRODUCER 7.5FR X 3.5
• Type of Device: CHOLANGIOGGRAM CATHETER
• Manufacturer (Section D): TELEFLEX; tecate ; MX
• Manufacturer Contact: effie jefferson, rn ; po box 12600; durham, NC 27709 ; 9194332672
• MDR Report Key: 3966555
• MDR Text Key: 17991278
• Report Number: 3003898360-2014-00435
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Type of Report: Initial
• Report Date: 06/18/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: PI-93
• Device Lot Number: 01B1400566
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2014
• Initial Date FDA Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1