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

Model Number	N/A
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/01/2024
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 manufacturer has received the sample and it will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by the customer, the shaft of the powerglide needle broke off in the patient while attempting to remove the housing once the vessel was cannulated (guidewire and catheter both were advanced w/o resistance).The device was secured, and the patient was sent to the ir suite to have the device removed.
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 break along the needle shaft is confirmed and was determined to be use-related.One 22 ga powerglide pro was returned for evaluation.An initial visual observation of the returned powerglide pro revealed blood use residues throughout the returned device.It was observed that the catheter was still attached to the needle shaft.The blue wings were observed to be broken off from the safety mechanism.The needle was observed to be broken towards the distal end of the needle tip.The guidewire was observed to be fully advanced through the needle shaft.The catheter was observed to be broken at the proximal end of the catheter.The distal end of the catheter was not returned for evaluation.A microscopic observation revealed the break site of the needle to have a granular fracture surface and flared fracture edges.The needle break was observed to be at the flash notch.The guidewire remained inside the needle shaft at the break site.The guidewire appeared to have several misaligned coils along the coil region of the guidewire.The catheter break was observed to be at the proximal end of the catheter.The break site was observed to have a chevron shape, and the fracture edges appeared sharp.Insertion techniques such as insertion angle, differences in tissue the device is being inserted into, or other unknown factors may have contributed to this event.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer, the shaft of the powerglide needle broke off in the patient while attempting to remove the housing once the vessel was cannulated (guidewire and catheter both were advanced w/o resistance).The device was secured, and the patient was sent to the ir suite to have the device removed.

• Brand Name: FULL KIT 22G X 8 CM WITH 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20540998
• Report Number: 3006260740-2024-06232
• Device Sequence Number: 8324926
• Product Code: FOZ
• UDI-Device Identifier: 00801741140648
• UDI-Public: (01)00801741140648(11)240725(17)250731(10)REJS4583
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/10/2025

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: 07/31/2025
• Device Model Number: N/A
• Device Catalogue Number: F222088PT
• Device Lot Number: REJS4583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 03/10/2025
• Initial Report FDA Received Date: 10/27/2024
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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