MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 8 CM WITH GUARDIVA AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a catheter break is confirmed.One powerglide pro device was returned without product packaging.The catheter and securement wings had been removed from the powerglide pro housing.The safety mechanism was fully activated over the needle bevel.The catheter was observed to contain multiple bends.A frayed section of the guidewire was found to be present within the catheter tubing.A longitudinal split in the catheter was noted at the region where the guidewire was located.Microscopic observation of the split surface revealed it to initiate with a slanted with peak in a ¿<¿ shape.The initiation point was also found to be bulging outwards.The split propagated 1.1 cm in length with the initial split occurring 4.3 cm from the distal end.The angle of the split and location of the damage is consistent with damage caused by the needle.This damage may occur if the needle is re-inserted after the catheter has been advanced.The product instructions for use (ifu) warns, ¿warning: once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.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.¿ since a complete break in the catheter was found, the complaint is confirmed.A lot history review (lhr) of refx4478 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "during a training with powerglide pro, nurse threaded guidewire without resistance and then tried to thread catheter off and felt resistance about halfway and stopped.Nurse then pulled back on wings.Threaded catheter again with not a lot of resistance just patient pulling arm back.Then she was instructed to safety catheter, when safety was activated guidewire appeared not to be in place.Catheter removed from patient.Not sign of trauma, however guidewire inside of catheter.Guidewire was not broken in patient arm, all of the guidewire is inside on catheter.We are having them take a x-ray of the patients arm and chest just to double check that none of the wire is still inside the patient.X-ray for right arm and chest ordered by clinician." (b)(6) 2022 - the returned sample exhibited a split and multiple bends.

• Brand Name: FULL KIT 20G X 8 CM WITH GUARDIVA AND PROBE COVER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15255337
• MDR Text Key: 305418878
• Report Number: 3006260740-2022-03228
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140570
• UDI-Public: (01)00801741140570
• 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: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• 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: F120088PT
• Device Lot Number: REFX4478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• 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 Outcome(s): Other