MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 10 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refy3735 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported "powerglide was placed in a patients upper arm and when viewed under xray appeared to be looped over its self dislodged in the arm.".

Event Description

It was reported "powerglide was placed in a patients upper arm and when viewed under xray appeared to be looped over its self dislodged in the arm.".

Manufacturer Narrative

H11: section a through f - the information provided by bd 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 bd.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.Three powerglide pro devices were returned with one product sticker label indicating lot:.Ref (b)(4).Two of the samples did not appear to have been used and were returned with the catheters present and needle protective cover.The two unused samples were returned labeled ¿good¿ and another sample labeled ¿bad¿.Both samples did not appear to have any damage.The two unused samples were inspected.The guidewires were able to advance successfully.The catheter was able to advance off the needle, and the safety mechanism successfully activated over the needle bevels.The third sample was returned with the catheter removed from the housing.The safety mechanism was fully activated over the needle bevel.The catheter was observed to contain a bend.A complete break in the catheter was noted.The catheter length measured to be 6.1 cm with the distal break segment not returned.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 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.H3 other text : evaluation findings are in section h11.

• Brand Name: FULL KIT 20G X 10 CM WITH BIOPATCH 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14648379
• MDR Text Key: 293712824
• Report Number: 3006260740-2022-02147
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140686
• UDI-Public: (01)00801741140686
• 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,Followup
• Report Date: 07/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• 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: F320108PT
• Device Lot Number: REFY3735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• 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