MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BASIC KIT 20G X 8 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number F320087T

Device Problems Kinked (1339); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 02/03/2018

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 device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of rebv2390 showed no other similar product complaint(s) from this lot number.Device has not yet been returned for evaluation.

Event Description

It was reported that during insertion, tenting under the skin was observed due to the catheter's failure to thread and kinking.Upon removal the guidewire was noted as bent and the catheter tip did not look intact.When the catheter tip was compared with a similar catheter tip, approximately 2 cm of catheter was unaccounted for.Patient did not exhibit any signs of distress at that time.Foreign body ultrasound was ordered for left arm; no ultrasound results reported at this time.

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 damaged catheter was confirmed and was determined to be related to use of the device.One 20g x 8cm powerglide pro catheter and deployment system were returned for investigation.The catheter was received separate from the deployment system.The catheter was still attached to the wings.The catheter tubing extended 6cm from the distal end of the pink strain relief sleeve, which indicates that approximately 2cm of the catheter was missing.The distal end of the catheter was not returned for investigation.The guidewire had been advanced through the needle and the safety mechanism had been activated.The needle was bent at the distal end of the deployment system.A microscopic examination revealed that the catheter was scored longitudinally within the lumen at the distal tip of the returned segment.The characteristics observed on the returned catheter are consistent with a needle puncture.Warnings in the ifu indicate that once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.This may result in damage to the catheter.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.The ifu also indicates to not perforate, tear, or fracture the catheter with the needle or guidewire during the procedure.Due to the evidence of use and the characteristics of the damage, the complaint was determined to be use related.A lot history review (lhr) of rebv2390 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that during insertion, tenting under the skin was observed due to the catheter's failure to thread and kinking.Upon removal the guidewire was noted as bent and the catheter tip did not look intact.When the catheter tip was compared with a similar catheter tip, approximately 2 cm of catheter was unaccounted for.Patient did not exhibit any signs of distress at that time.Foreign body ultrasound was ordered for left arm; no ultrasound results reported at this time.

• Brand Name: BASIC KIT 20G X 8 CM WITH BIOPATCH
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7303155
• MDR Text Key: 101368694
• Report Number: 3006260740-2018-00293
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140525
• UDI-Public: (01)00801741140525
• 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: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F320087T
• Device Catalogue Number: F320087T
• Device Lot Number: REBV2390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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
• Patient Age: 66 YR
• Patient Weight: 69