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	08/25/2025
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.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 customer that the powerglide sheared during insertion, tip missing from catheter.Hospital completed x-ray but tip was not located.During insertion, no resistance was felt with guidewire, then clinician went to thread catheter and met resistance about halfway down.Talk through details with her and clinical specialist and it sounds like catheter was pulled back over needle after resistance was met.
Event or Problem Description
Additional information received on 9/17/2025: nothing was found on x-ray.The event did not involve an urgent or life-threatening situation, and there was no clinically significant delay.The patient did undergo a couple of x-rays that otherwise would not have been exposed to.Iv antibiotics were to be infused.A new catheter was placed.There was no patient harm or negative outcome.
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 break in the catheter is confirmed and was determined to be use-related.One 20 ga powerglide pro was returned for evaluation.An initial visual observation revealed blood residues throughout the returned device.It was observed that the safety mechanism was not advanced over the needle tip.The guidewire was not advanced upon the return of the device.The catheter was observed to be broken along the catheter shaft.The distal end of the catheter was not returned for evaluation.A microscopic observation revealed a chevron-shaped break in the catheter with a shiny fracture surface and sharply formed fracture edges.The characteristics of the break suggested the break likely occurred from pulling the catheter shaft against the needle.An examination of the catheter structure revealed no potential damage/defect related to the manufacture of the product.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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23083295
• Report Number: 3006260740-2025-07042
• Device Sequence Number: 4748643
• Product Code: FOZ
• UDI-Device Identifier: 00801741140624
• UDI-Public: (01)00801741140624(11)250609(17)260630(10)REKR1529
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2025

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: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: F220088PT
• Device Lot Number: REKR1529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 09/19/2025; 10/13/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/09/2025; 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2025
• 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