MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO; MIDLINE CATHETER

Catalog Number	F218101T
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the guidewire was coiled.No patient impact.
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.The device has not been returned to the manufacturer for evaluation.
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.
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 guidewire break is confirmed and was determined to be use-related.One 18 ga powerglide pro device was returned for evaluation.An initial visual observation of the returned powerglide pro device showed blood residues throughout the device.The safety mechanism was engaged over the needle tip upon the return of the device.The guidewire appeared to extend out of the distal needle shaft, and the guidewire appeared unraveled.A microscopic observation of the guidewire of the returned powerglide pro device showed the distal weld tip was still present at the distal end of the guidewire.A break in the core wire was observed along the guidewire, contributing to the coil wire of the guidewire unraveling during use of the product.The proximal and distal core wire break sites were accounted during microscopic inspection of the guidewire.The proximal break site of the core wire appeared angled with a granular, flat fracture surface.The distal break site of the core wire of the guidewire was observed to be broken at an angle with a granular, flat fracture surface.The break site and break location of the core wire was observed to have characteristics of the guidewire being pulled against the needle bevel of the device.No potential damage/defect related to the manufacture of the device was observed upon the return of the device.Pulling the guidewire back against the needle bevel may cause a break in the guidewire of the device.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERGLIDE PRO
• Common Device Name: MIDLINE CATHETER
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23128912
• Report Number: 3006260740-2025-07150
• Device Sequence Number: 7393739
• Product Code: FOZ
• UDI-Device Identifier: 00801741142758
• UDI-Public: (01)00801741142758(11)250725(17)260831(10)REKT2229
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 11/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: F218101T
• Device Lot Number: REKT2229
• 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: 09/10/2025
• Supplement Date Received by Manufacturer: 10/07/2025; 11/06/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 10/23/2025; 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2025
• 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: Other
• Patient Sex: Unknown