MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FULL KIT 18G X 10 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889)

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

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rect0480 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that a newly trained inserter was placing a line in the vessel, and the catheter would not advance.The device was pulled from the patient's arm and it was found that the guide wire was missing.Originally the staff believed that the guide wire was lost, and possibly in the patient.Patient was taken to ir, but nothing was found.Eventually it was found that the guide wire had retracted into the device.9/25/2018 (additional information) returned wire is kinked.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of ¿the guidewire had retracted into the device¿ was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 18ga x 10cm powerglide pro rt midline catheter assembly.Usage residues were observed in the needle and catheter.The catheter was advanced off of the needle and the safety mechanism was engaged over the needle bevel.The guidewire slider was advanced; however, the wire did not protrude from the needle tip.The wire was not attached to the advancer.Following disassembly of the housing and removal of the guidewire, inspection of the wire confirmed the tip to be intact.Several misaligned coils were observed near the weld tip.Microscopic inspection of the guidewire advancer revealed wear markings consistent with guidewire contact.Inspection of the wire confirmed several misaligned coils near the weld tip.Inspection of the needle bevel revealed mechanical damage along the proximal edge.Inspection of the catheter revealed deformation and discoloration of the distal tip.The wear markings on the guidewire advancer indicated that the wire was originally properly engaged with the advancer.The guidewire coil misalignments, catheter deformation and needle bevel damage suggested that wire advancement was attempted against resistance, possibly into tissue.The blood residue suggested the damage occurred during attempted device placement.A lot history review (lhr) of rect0480 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that a newly trained inserter was placing a line in the vessel, and the catheter would not advance.The device was pulled from the patient's arm and it was found that the guide wire was missing.Originally the staff believed that the guide wire was lost, and possibly in the patient.Patient was taken to ir, but nothing was found.Eventually it was found that the guide wire had retracted into the device.

• Brand Name: FULL KIT 18G X 10 CM WITH BIOPATCH AND PROBE COVER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: heather murphy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225738
• MDR Report Key: 7971362
• MDR Text Key: 123950229
• Report Number: 3006260740-2018-02904
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140662
• UDI-Public: (01)00801741140662
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2018

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 Model Number: N/A
• Device Catalogue Number: F318108PT
• Device Lot Number: RECT0480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/24/2018
• Initial Date FDA Received: 10/16/2018
• Supplement Dates Manufacturer Received: 09/25/2018
• Supplement Dates FDA Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• 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