MAUDE Adverse Event Report: BARD ACCESS SYSTEMS VAS-CATH NIAGARA KIT 13.5 F X 24 CM [SHORT TERM DUAL-LUMEN]; NON-IMPLANTED BLOOD ACCESS DEVICE

Model Number 5593240

Device Problems Difficult to Insert (1316); Material Integrity Problem (2978)

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

Event Date 07/24/2017

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 reaz0887 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that during the placement of the device, the guidewire stuck in the puncture needle.It was impossible to remove the needle which became elastic and brittle.No patient injury reported.

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 that the guidewire became stuck in the introducer needle was confirmed and the damage appeared to be related to use of the device.One 0.038¿ guidewire was received within an 18g introducer needle.The distal tip of the guidewire was lodged in the needle.The guidewire was not extending from the distal tip of the introducer needle.A microscopic examination of the 18g introducer needle revealed that the inner edge of the opening at the needle bevel was deformed.Blood residue was visible within the needle.It was noted that the core wire broke at the distal weld tip, which allowed the coil wire to stretch over the core wire.The guidewire was forcefully pulled from the introducer needle.Biological material was found on the section of coil wire that was within the introducer needle.The damage at the needle bevel and the presence of biological residue lodged between the guidewire and needle indicate that the guidewire was retracted within the introducer needle.The outside diameter (od) of the guidewire was found to be within specification.The product ifu indicates to not pull back guidewire over needle bevel as this could sever the end of the guidewire.The introducer needle must be removed first.

Event Description

It was reported that during the placement of the device, the guidewire stuck in the puncture needle.It was impossible to remove the needle which became elastic and brittle.No patient injury reported.

• Brand Name: VAS-CATH NIAGARA KIT 13.5 F X 24 CM [SHORT TERM DUAL-LUMEN]
• Type of Device: NON-IMPLANTED BLOOD ACCESS DEVICE
• 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: 6835450
• MDR Text Key: 84878078
• Report Number: 3006260740-2017-01474
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045585
• UDI-Public: (01)00801741045585
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K030268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

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 Expiration Date: 12/31/2019
• Device Model Number: 5593240
• Device Catalogue Number: 5593240
• Device Lot Number: REAZ0887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2017
• Supplement Dates Manufacturer Received: 10/27/2017
• Supplement Dates FDA Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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