MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (19CM); BLOOD ACCESS AND ACCESSORIES

Model Number 5833690

Device Problems Difficult to Remove (1528); Sticking (1597); Failure to Advance (2524)

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

Event Date 03/20/2018

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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reby1895 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reby1895) have been reported from the same facility.

Event Description

The guidewire was stuck within the needle upon insertion and failed to insert and remove.There was no reported patient injury.This file addresses the first of two devices.

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 guidewire stuck within the needle is confirmed, and the cause is determined to be use-related.The sample returned consisted of one pink-hubbed introducer needle and 1 70-cm guidewire.Visual observation found the needle to be over the guidewire near the j-tip end.The wire was bending/curling.Residue was found on the needle.Further examination found the core wire to be broken at the distal weld tip.Tactual evaluation found that the needle was immobile on the wire.Microscopic evaluation found that there was unknown somewhat fibrous material between the needle and the wire at the needle tip.There was significant residue that appeared to be biological.There appeared to be some tapering at the distal tip of the broken core wire and some damage to the inner bevel on the needle tip.This is consistent with breakage of the wire due to excessive tensile forces and/or withdrawing the wire against the needle.It is also apparent that the wire became immobile because the wire was pulled back while in the needle, drawing unknown material into the space between the wire and the needle.The complaint is therefore determined to be use-related.The ifu states not to withdraw the wire while it is inside the needle.The needle must be withdrawn before the guidewire is retracted.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 reby1895 showed no other similar product complaint(s) from this lot number.

Event Description

The guidewire was stuck within the needle upon insertion and failed to insert and remove.There was no reported patient injury.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (19CM)
• 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: 7485092
• MDR Text Key: 107449076
• Report Number: 3006260740-2018-00879
• 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: Other Caregivers
• Type of Report: Initial,Followup
• Report Date: 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5833690
• Device Catalogue Number: 5833690
• Device Lot Number: REBY1895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2017
• 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