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	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/20/2026
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.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 the catheter broke inside the patient¿s arm during insertion.She stated that this is the only incident of this kind and that the same clinician had successfully inserted another catheter earlier the same day without any issues.The catheter was removed by an interventional radiologist.There were no complications during or following the procedure.The midline was replaced in the ir department.
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 catheter is confirmed and was determined to be related to use of the product.One 20 ga x 8 cm powerglide pro catheter with its attached wings were returned for evaluation.An initial visual observation of the returned catheter showed use residues throughout the catheter.A chevron-shaped break was observed at the distal portion of the returned catheter.The broken distal catheter fragment was not returned for evaluation.A microscopic observation of the returned catheter break site revealed sharp fracture edges and a shiny, granular fracture surface.Inspection of the catheter break showed a chevron-shaped break site which was consistent with pulling the catheter shaft back against the needle bevel of the powerglide pro device.Pulling the catheter back against the needle may cause a split or break along the catheter shaft during catheter insertion.The powerglide pro ifu states, "once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter." 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): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; parque industrial colonial; salt lake city UT 84116
• Manufacturer Contact: becky sparks ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24251497
• Report Number: 3006260740-2026-00437
• Device Sequence Number: 18546346
• Product Code: FOZ
• UDI-Device Identifier: 00801741142666
• UDI-Public: (01)00801741142666(11)251109(17)270228(10)REKX0047
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/20/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F120080T
• Device Lot Number: REKX0047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2025
• 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