MAUDE Adverse Event Report: TELEFLEX TAUT CHOLANGIOGRAM CATHETER 10/BOX 4.5 FR TIP

Catalog Number 18400

Device Problems Migration or Expulsion of Device (1395); Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/25/2014

Event Type  malfunction  

Event Description

Alleged issue: customer received five boxes labeled 18400 on the packaging on the box the packaging on the catheter but what they received was the 18305's inside of the packaging.No pt involvement.This was mde reportable because the catalog# 18400 with that lot# are missing the metal tube insert and this could be a problem if the surgeon tries to crimp it to hold it in place.Without the metal tube the end of the tube could shear off.No reported pt injury.Pt's condition reported as fine.

Manufacturer Narrative

Device sample not received by mfg.Per dhr the product taut cholang cath10/bx 4.5 fr tip x 30, lot # 01a1400037 was manufactured on 01/08/2014 a total of (b)(4) pieces.Lot was released on 01/09/2014.Corrective actions: personnel was notified of the missing support tube; the device documentation was revised to establish the necessary controls to prevent re-occurrence of this issue.Dhr review confirmed defect reported by customer "wring size product in package".The operator confused the 18400 operation, that requires crimping, with the 18305, that does not require this operation.This is why the customer reported the 18305's inside of the packaging.Personnel were made aware of the missing support tube and controls were established to prevent re-occurrence.It is noted that this defect is isolated only to lot 01a1400037 and that no other lots were affected, however, we will continue to monitor and trend related complaints.

• Brand Name: TAUT CHOLANGIOGRAM CATHETER 10/BOX 4.5 FR TIP
• Type of Device: CHOLANGIOGRAM CATHETER
• Manufacturer (Section D): TELEFLEX; tecate ; MX
• Manufacturer (Section G): TELEFLEX; prolongacion mision eusebio
• Manufacturer Contact: elaine burke, rn, regulatory aff ; po box 12600; rtp, NC 27709 ; 9194334957
• MDR Report Key: 3886405
• MDR Text Key: 4546333
• Report Number: 3003898360-2014-00221
• Device Sequence Number: 1
• Product Code: GBZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 18400
• Device Lot Number: 01A1400037
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1