MAUDE Adverse Event Report: C.R. BARD ACCESS SYSTEMS INC. POLY PER Q-CATH PICC 4F SINGLE-LUMEN NURSE BASIC TRAY WIT; LJS

Catalog Number 3154115

Device Problem Mechanics Altered (2984)

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

Event Type  malfunction  

Event Description

Braiding on wire came off at certain points.It appears that someone cut it.

Manufacturer Narrative

The complaint of a damaged stylet was confirmed; however the cause of this damage remains unknown.The product returned for evaluation was photo samples of a black-tabbed hydrophilic coated wire stiffening stylet with the red warning label attached.There were seven photos sent from the complainant facility - five being of the stylet, one being of the product catalog reference number and lot number label, and one being of the business card of complainant.Gross examination of the stylet photos revealed that the distal end appeared to be split.The stylet also appeared to be heavily kinked at the juncture of the split, as well as having kinks/bends throughout the stylet.One side of the split appeared to be thinner, shorter, and curved at the distal end.Three of the photos had the stylet next to what appeared to be a ruler, but the units of measurement were unknown.Without receipt of the physical sample, neither further investigation of this damage nor the root cause of it could be determined at this time.The event description states that this wire appeared to be cut, which would need to be confirmed under microscopic examination.A lot history review (lhr) of rexl0597 showed no other similar product complaint(s) from this lot number.

• Brand Name: POLY PER Q-CATH PICC 4F SINGLE-LUMEN NURSE BASIC TRAY WIT
• Type of Device: LJS
• Manufacturer (Section D): C.R. BARD ACCESS SYSTEMS INC.; 605 north 5600 west; 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: shelly gilbert ; 605 north 5600 west; salt lake city, UT 84116-0000 ; 8015950700
• MDR Report Key: 3886542
• MDR Text Key: 4541778
• Report Number: 3006260740-2014-00174
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2014

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3154115
• Device Lot Number: REXL0597
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2014
• Initial Date FDA Received: 04/11/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2013
• 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