MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET BASIC TRAY (30 CM); PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number 4132105

Device Problem Kinked (1339)

Patient Problem No Information (3190)

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, at this time, for evaluation.A lot history review (lhr) of rezk0210 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported after inserting catheter to patient, the catheter became kinked while withdrawing guide wire.This file is for the second reported event.

Manufacturer Narrative

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 kinked catheter was confirmed and the cause appeared to be use related.The product returned for evaluation was two 2fr perqcath piccs.Both catheters were returned with the stiffening stylet inlaid within the catheters and both contained red blood-like residue on the catheter exteriors.Gross visual evaluation of the catheters confirmed the presence of catheter bunching on the sample marked ¿2¿ and no kinking or bunching was seen on the sample marked ¿1¿.Microscopic examination of catheter ¿2¿ found no apparent manufacture defect.The stylets were wetted by flushing through the t-lock assemblies and both were easily withdrawn from the catheters; no resistance was encountered.The catheter bunching of sample ¿2¿ released upon infusion through the t-lock and the stylet easily released.Microscopic examination of both the catheter and stylet of that sample was unremarkable.No apparent manufacture cause was seen on the devices.This type of event can occur if the stylet is not properly wetted prior to the withdrawal attempt.A red hang tag on the stylet instructs to ¿flush catheter prior to use¿.Additionally, the product ifu provides the following instruction, ¿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 2cm 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.¿ for evaluation.A lot history review (lhr) of rezk0210 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported after inserting catheter to patient, the catheter became kinked while withdrawing guide wire.This file is for the second reported event.

• Brand Name: PER-Q-CATH PLUS 2F SINGLE-LUMEN PICC WITH STIFFENING STYLET BASIC TRAY (30 CM)
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• 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: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 7022688
• MDR Text Key: 92918160
• Report Number: 3006260740-2017-02011
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741074837
• UDI-Public: (01)00801741074837
• Combination Product (y/n): N
• PMA/PMN Number: K954104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4132105
• Device Catalogue Number: 4132105
• Device Lot Number: REZK0210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2015
• 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