MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 FULL KIT 22G X 8 CM WITH BIOPATCH AND PROBE COVER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	F322088PT
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Additional 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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by customer that during placement of catheter in the left cephalic vessel a positive blood return was noted.The vessel size was at 0.32 cm, almost 1 cm deep the vessel was accessed and the wire slid without complication, when inserting the catheter it was ¿sticky¿, and the patient complained of pain.A bulge started forming just proximal to the insertion site, close to the 4cm proximal.Catheter placement was aborted, the wire was unable to withdraw.The patient is now complaining of a lot of pain and the catheter had disconnected from the hub so all that was exposed from the skin was the access needle.The catheter could not be seen.The arm and catheter was wrapped in kerlex for patient comfort until the line could be removed.Xray and ct completed.Ir removed the stuck guidewire but with the catheter not being attached to the hub it didn't come out with the wire.The following day ir removed the entire device which measured just under 7.8cm long.This was an indication that the entire catheter was retrieved as ½ cm was still attached to the hub and this was an 8cm catheter.No other information provided, at this time.
Additional 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 complaint of a broken catheter was confirmed, but the root cause could not be determined.The product returned for evaluation was one 22g powerglide pro device.A gross visual inspection of the returned unit found that the catheter was broken into two pieces near the nose of the catheter hub.Microscopic inspection of the break site found that the break had a v-shape, likely indicating that the break originated as a tear from the needle piercing through the catheter tubing.Surrounding the break were several tear sites which had evidence of needle spear through damage.Throughout the tubing were multiple areas of material buckling, suggesting that the catheter was inserted against resistance.Inspection of the catheter tip found buckling and deformation of the tip edge, further suggesting that the catheter was inserted against resistance.Inspection of the guidewire found that guidewire was still intact and had not unraveled.Misaligned guidewire coils were observed throughout the flexible portion of the wire.The event description suggests that heavy manipulation was necessary to remove the catheter from the patient.Therefore, it is unknown if the damage observed on the catheter tubing was caused by the manipulation performed by the clinician during catheter removal.The other features observed indicate that the catheter was inserted against resistance.However, the features do not provide enough evidence to conclusively determine a root cause.Therefore, the root cause remains unknown.

• Brand Name: FULL KIT 22G X 8 CM WITH BIOPATCH AND PROBE COVER
• Common Device Name: 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: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21160261
• Report Number: 3006260740-2025-00026
• Device Sequence Number: 20726205
• Product Code: FOZ
• UDI-Device Identifier: 00801741140693
• UDI-Public: (01)00801741140693(11)231129(17)250131(10)REHY0621
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: F322088PT
• Device Lot Number: REHY0621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown