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

Catalog Number	F120108PT
Medical Device Problem Codes	Break (1069); Material Frayed (1262); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
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 will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by the customer that the guidewire detached from the device and remained inside the patient arm.It was reported that the guidewire later back tracked out of the patient arm and was removed.No major injury was noted based on subsequent imaging, and the guidewire was intact.The catheter was intact and flushed with no evidence of shearing.Staff reported that the insertion had been smooth, but when the catheter was threaded the patient experienced severe pain and the entire device was removed.The staff did not initially notice that the guidewire was missing, and it was found protruding from the arm approximately fifteen minutes later.No further information provided.
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 split in the powerglide pro catheter is confirmed and was determined to be use-related.One 20 ga powerglide pro device was returned for evaluation.An initial visual observation of the returned device showed abundant blood residues throughout the powerglide pro housing, catheter, and guidewire.The safety mechanism was advanced over the needle tip upon the return of the device, and the needle shaft was bent approximately halfway down the needle shaft.The guidewire was broken upon the return of the device.The guidewire inside the housing was observed to be looped and twisted.The distal fragment of the guidewire was returned for evaluation.A microscopic observation of the returned guidewire fragment revealed the distal weld tip was present along the device.The core wire break site was observed to be bent slightly at an angle with a flat, granular fracture surface.The coil wire break was observed to be at an angle with a granular fracture surface.The powerglide pro housing was carefully taken apart, and the proximal guidewire section was carefully removed from the needle shaft.The proximal break section of the coil wire along the guidewire was observed to be elongated and stretched.These features of the break correlate to the guidewire being pulled back against the powerglide pro needle bevel, causing the guidewire to shear during insertion and removal 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: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24461656
• Report Number: 3006260740-2026-01218
• Device Sequence Number: 21166214
• Product Code: FOZ
• UDI-Device Identifier: 00801741140587
• UDI-Public: (01)00801741140587(11)251120(17)261130(10)REKW2439
• Combination Product (Y/N): Y
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2026

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 Catalogue Number: F120108PT
• Device Lot Number: REKW2439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: 03/17/2026; 04/03/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/20/2026; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2025
• 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