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

Model Number N/A

Device Problems Kinked (1339); Sticking (1597); Unraveled Material (1664)

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

Event Date 06/23/2017

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 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 could not be removed from 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 extended 4.7cm 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.A translucent fibrous biological material, which could be tissue residue, 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needle bevel and the presence of biological residue lodged between the guidewire and needle indicate that the guidewire was retracted within the introducer needle.The outside diameter (od) of the guidewire was found to be within specification.The product ifu indicates to not pull back 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) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that the guidewire got stuck within the needle guide.No other information was given.No patient harm was reported.The returned guidewire was kinked and unraveled.

• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6993400
• MDR Text Key: 91302061
• Report Number: 3006260740-2017-01928
• 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: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5833690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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