MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (; BLOOD ACCESS AND ACCESSORIES

Model Number 5833690

Device Problem Sticking (1597)

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

Event Date 01/15/2018

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 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 guidewire getting stuck in an introducer needle is confirmed and found to be use-related.The sample returned consisted of a pink-hubbed introducer needle and one guidewire with its hoop.A label was also returned identifying the product in question as 5833690, lot number rebw0488.Visual observation found that the guidewire was within the needle, with only the j-tip sticking out the distal end.Microscopic evaluation found an accumulation of use residues at the junction of the distal needle tip and the guidewire.The needle could not initially be removed, but was possible after soaking and pulling the wire distally relative to the needle.Once completely out of the area it had once occupied, the needle retracted without difficulty.The outer diameter of the wire measured within specification.When the needle was removed from the wire, a large agglomeration of solid biological residue was found where the tip of the needle had been, potentially tissue.Blood was also under the region covered by the needle.Damage from the coils of the wire was found on the needle bevel.The core wire was found to be broken very near the distal weld tip.The ends of the core wire were somewhat tapered.This damage is typical of retraction of the wire against/into the needle, resulting in blockage of the needle and wire/needle damage.The ifu states: ¿ do not pull back standard guidewire over needle bevel as this could sever the end of the guidewire.The introducer needle must be removed first.¿ a lot history review (lhr) of rebw0488 showed one other similar product complaints from this lot number.

Event Description

It was reported the guidewire got stuck in the introducer needle.There was no reported patient injury.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (
• Type of Device: BLOOD ACCESS AND ACCESSORIES
• 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: 7496940
• MDR Text Key: 107823500
• Report Number: 3006260740-2018-00911
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013386
• UDI-Public: (01)00801741013386
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 5833690
• Device Catalogue Number: 5833690
• Device Lot Number: REBW0488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• 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