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	02/24/2025
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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported vis medwatch that ultrasound guided powerglide midline (18 g 8 cm) insertion was attempted.Sterile procedure per protocol and needle tip seen within vessel.Guidewire deployed without complication; however, catheter would not glide over wire.After second failed attempt of catheter gliding over guidewire, inserter decided to remove entire midline catheter.Needle removed and safety deployed without complication.Upon removing catheter, inserter met resistance once approximately 6 cm of catheter removed from patient's arm.Catheter was secured to patient's arm with tegaderm and a chest/arm xray was completed.Catheter and guidewire removed.Additional chest/arm xray completed after removal.Guidewire appears to have come lose from device and catheter tip not intact.The catheter was 7 cm upon removal.Approximately 1 cm of retained midline catheter in patient's left arm.No other information was provided.

• 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: jomil padin ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21915644
• Report Number: 3006260740-2025-02618
• Device Sequence Number: 15631523
• Product Code: FOZ
• UDI-Device Identifier: 00801741140655
• UDI-Public: (01)00801741140655(11)241202(17)251130(10)REJW1460
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2025

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: 11/30/2025
• Device Model Number: N/A
• Device Catalogue Number: F318088PT
• Device Lot Number: REJW1460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 04/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2024
• 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 Age: 42 YR
• Patient Sex: Male