MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 PowerGlide Pro; Midline Catheter

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer that powerglide shearing off the tip yesterday and getting stuck in a patient.Additional information received: it was retained in the tissue per ct scan.It was not removed.They monitored patient for multiple days and patient had no symptoms and the vascular surgery provider recommended no follow up surgery.During insertion, guidewire mechanism was engaged with no resistance but attempt to move midline mechanism forward and halfway in met resistance.Attempted to retract and was met again with resistance.Midline was removed entirely with the retracting resistance.They had done a ct scan that had shown it in patient arm, venogram was done to confirm it was not in the vein.No additional intervention aside from the diagnostic testing post procedure for catheter location.No further details 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.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.

• 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; +1(801)595-0700
• MDR Report Key: 50144100
• Report Number: 3006260740-2026-05329
• Device Sequence Number: 10730903
• Product Code: FOZ
• UDI-Device Identifier: 00801741142758
• UDI-Public: (01)00801741142758(11)260511(17)270531(10)RELQ2194
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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
• Report Date (Section B): 07/17/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F218101T
• Device Lot Number: RELQ2194
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2026
• 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