MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4.5 FR UNIVERSAL MICRO INTRODUCER KIT WITH PTFE; CATHETER INTRODUCER

Catalog Number 0668945

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reas1354 showed three other similar product complaint(s) from this lot number.All complaints for this lot number (reas1354) have been reported from the same chinese facility.

Event Description

It was reported by nurse that there were burrs on the tail end of the guidewire.No patient injury reported.No other event information provided at this time.This report relates to guidewire four.

• Brand Name: 4.5 FR UNIVERSAL MICRO INTRODUCER KIT WITH PTFE
• Type of Device: CATHETER INTRODUCER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: maren treft ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225964
• MDR Report Key: 6322190
• MDR Text Key: 67394807
• Report Number: 3006260740-2017-00056
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741074530
• UDI-Public: (01)00801741074530(17)190728(10)REAS1354
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Catalogue Number: 0668945
• Device Lot Number: REAS1354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1