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 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, at this time, for evaluation.A lot history review (lhr) of rezj1749 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.

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 was determined to be use related.The product returned for evaluation was a 2fr perqcath catheter with inlaid stiffening stylet.Gross visual evaluation found extensive blood-like usage residue on and within the catheter and the catheter itself was bunched up against the strain relief.Microscopic examination of the catheter found no potential manufacture damage, defect, or deformity in the exterior catheter.The stylet was withdrawn from the catheter by gentle pulling of the stylet.Hardened blood-like residue was adhered to the stylet.No damage, defect, or deformity was observed on the stylet.Further microscopic examination revealed the presence of a catheter hole in the catheter near the previously bunched up region.The hole was tapered inwards and granular towards the inner catheter surface; all of which is indicative of stylet-induced damage.This type of damage can occur if the stylet is forcefully removed from the picc.The product ifu 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.¿ a lot history review (lhr) of rezj1749 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported after inserting the catheter in the patient, the catheter became kinked while withdrawing the guidewire.

• 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: 7022454
• MDR Text Key: 92916086
• Report Number: 3006260740-2017-02007
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741074837
• UDI-Public: (01)00801741074837
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 12/15/2017

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: REZJ1749
• 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: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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