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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/24/2025
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.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 date of event was not provided by the complainant/reporter; the date reflected in this report is the date on which bd became aware of the event.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported that while putting the power glide in the patient it got stuck.The engagement slide got stuck upon withdrawing the catheter tip remain in the patient but was able to remove it.Patient did not have to go to the emergency room.
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 in the guidewire is confirmed and was determined to be use-related.One 18 ga powerglide pro was returned for evaluation.An initial visual observation of the returned powerglide pro showed abundant blood residues throughout the returned device.The safety mechanism was engaged over the needle tip upon the return of the device.The guidewire was advanced with an observed bend along the guidewire where it exits the distal needle shaft.The returned catheter was observed to be broken at the distal end of the catheter.Both sections of the catheter were returned for evaluation.A microscopic observation revealed a chevron-shaped break along the distal end of the catheter shaft.The fracture surface was shiny and uneven, while the fracture edges appeared sharp and uneven.A split was observed extending from the break site proximally.The catheter may break upon insertion if it is pulled against the needle bevel, causing a diagonal, or chevron-shaped split in the catheter tubing.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERGLIDE PRO, REINFORCED TIP
• 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: kelly m. rackley ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22783087
• Report Number: 3006260740-2025-05727
• Device Sequence Number: 8127896
• Product Code: FOZ
• UDI-Device Identifier: 00801741142659
• UDI-Public: (01)00801741142659(11)250408(17)261130(10)REKP2646
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 09/12/2025

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 Model Number: N/A
• Device Catalogue Number: F118100T
• Device Lot Number: REKP2646
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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: Required Intervention
• Patient Sex: Unknown