MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 6 FR DL POWERLINE CATHETER, MICROINTRODUCER KIT; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Catalog Number 0700615

Device Problems Detachment Of Device Component (1104); Torn Material (3024)

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 following were reviewed as part of this investigation: patient severity, trend 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 tear near the red hub was confirmed, and it appears that the damage occurred during use.One 6 fr d/l powerline catheter was returned for investigation.The returned powerline catheter reveals evidence of use.The dual lumen (d/l) tubing extended 9cm from the distal end of the surecuff.Blood residue was observed within the fibers of the cuff.Residue, which could be from an adhesive dressing, was observed on the bifurcation, extension legs, clamps, and connectors.The printing on the bifurcation was partially worn.Sutures were tied through each hole in the suture wing.The cross section at the distal end of the catheter revealed a glossy and striated surface, which is indicative of a sharp instrument cut that was made at the time of trimming the catheter.A functional test revealed a leak in the extension leg tubing just inside the distal end of the red hub.The leak site in the extension leg was microscopically examined and a tear in the circumferential direction was found.The adjoining surfaces the tubing was noted to be rough and granular, which is indicative of a tear in the material.It is possible that the tubing tore from manipulation during repeated access of the luer adaptor, involving flexing and twisting.It is unknown if other factors, such as chemical degradation, were involved.Due to the condition of the returned device, it appears that the catheter was damaged during use.A lot history review (lhr) of reau2403 showed no other similar product complaint(s) from this lot number.

Event Description

Per sales rep, the facility reported that the cap broke off one of the lumens.Additional information has been requested.On (b)(6) 2017 - evaluation found a tear on the extension leg just distal to the red connector.

• Brand Name: 6 FR DL POWERLINE CATHETER, MICROINTRODUCER KIT
• 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6485915
• MDR Text Key: 72794659
• Report Number: 3006260740-2017-00399
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741036606
• UDI-Public: (01)00801741036606(17)210328(10)REAU2403
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Catalogue Number: 0700615
• Device Lot Number: REAU2403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 02/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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