MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS PICC 3F WITH STIFFENING STYLET WIRE (SINGLE-LUMEN) (65 CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 4133105

Device Problem Hole In Material (1293)

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

Event Date 05/21/2018

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 rebw0230 showed three other similar product complaint(s) from this lot number.

Event Description

It was reported that prior to use on patient, during preflushing, it was observed by the team that the catheter had a hole.This report addresses the first of three devices.

Event Description

It was reported that prior to use on patient, during reflushing, it was observed by the team that the catheter had a hole.This report addresses the first of three devices.

Manufacturer Narrative

H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak in the per-q-cath picc was confirmed, and the damage appeared to be associated with use of the device.One 3fr s/l per-q-cath picc was returned for investigation.The picc was received with the stylet in the lumen.A functional test revealed a leak at the distal end of the molded taper near the 0 mark.After flushing the catheter, the stylet was removed without difficulty.The leak site was microscopically examined and a hole was visible in the tubing at the leak site.The catheter was bisected and a longitudinal split was observed on the inner lumen wall.The damage observed on the inner lumen wall was greater than the damage observed on the external surface of the tubing.The adjoining surfaces of the split tubing revealed a granular appearance.Since the extent of damage was greater on the inner lumen wall, it was determined that the catheter was damaged from within the lumen.This type of damage can occur when the stylet is repositioned within the picc without flushing the catheter.The product ifu states, ¿flush the catheter with sterile normal saline or heparinized saline prior to use.Catheter stylet must be wetted prior to stylet repositioning or withdrawal.¿ the ifu also cautions, ¿never use force to remove the stylet.Resistance can damage the catheter.If resistance or bunching of the catheter is observed, stop stylet withdrawal and allow the catheter to return to normal shape.Withdraw both the catheter and stylet together approximately 2 cm and reattempt stylet removal.Repeat this procedure until the stylet is easily removed.Once the stylet is out, advance the catheter into the desired position.¿ a lot history review (lhr) of rebw0230 showed three other similar product complaint(s) from this lot number.

• Brand Name: PER-Q-CATH PLUS PICC 3F WITH STIFFENING STYLET WIRE (SINGLE-LUMEN) (65 CM)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7604007
• MDR Text Key: 111849453
• Report Number: 3006260740-2018-01407
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741074844
• UDI-Public: (01)00801741074844
• Combination Product (y/n): N
• PMA/PMN Number: K954104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 4133105
• Device Catalogue Number: 4133105
• Device Lot Number: REBW0230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Event Location: Hospital
• Date Manufacturer Received: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1