MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH

Catalog Number 066845

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/03/2014

Event Type  malfunction  

Event Description

It was reported that when the head nurse was puncturing the picc, the puncture process of the vascular sheath was successful.The guidewire was retrieved after the body position was well adjusted.However, the retrieved guidewire has been pulled straight.

Manufacturer Narrative

This complaint is confirmed and will be considered user related.The damaged incurred to the guidewire exhibits severe tensile elongation of the outer coils, separation of the center wire and a section of the wire that has been severed.During the placement procedure, the user should not pull back the guidewire over the needle as this may damage or severe the end of guidewire.It should be noted that the distal weld tip has severed from the center core wire and is missing from the distal end of the guidewire.A lot history review (lhr) of rexg0069 showed no other similar product complaint(s) from these lot numbers.

• Brand Name: UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH
• Manufacturer (Section D): BARD ACCESS SYSTEMS; salt lake city UT
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: christy chandomia ; 605 north 5600 west; salt lake city, UT 84116 ; 8015224969
• MDR Report Key: 4209030
• MDR Text Key: 5147665
• Report Number: 3006260740-2014-00536
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K915167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 066845
• Device Lot Number: REXG0069
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/01/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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
• Patient Outcome(s): Required Intervention