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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
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 it will be evaluated.A supplemental report will be submitted with evaluation results.
Event or Problem Description
It was reported that during a bedside powerglide pro insertion, the customer advanced the guidewire, stated she felt no resistance, and threaded the catheter into the skin.She went to retract the needle and device, she said it felt stuck.She tried to remove the needle and device from the catheter once more and said it was still stuck.She went to remove the entire device and catheter from the skin.When she attempted to do so, she said it also felt stuck.She gently tried again and was unable to remove it.There was an observed tear in the catheter that was immediately outside of the insertion site.The attending was called to come and assess the situation.The attending came down and was able to retrieve the catheter and device using a suture removal kit.He made a small skin nick at the insertion site and slowly pulled out the catheter with tweezers.The tip of the wire and the tip of the catheter were both inspected and both remained intact.
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 damaged powerglide pro device is confirmed; however, the exact cause is unknown.Seven photographs of a powerglide pro were returned for evaluation.An initial visual observation of the photographs showed the product with a catheter that was bent in several locations and a hole near the catheter hub.The guidewire was also bent in several locations.Use residue could be seen in the catheter tubing.There were no distinguishing features in the returned photographs of the device which could aid in identification of a specific root cause.The root cause of the initial difficulty retracting the needle could not be determined.Although the exact mechanism of damage is unknown, it is likely that the hole in the catheter was a cascading event that occurred during the attempted insertion or removal of the device.This complaint will be recorded for future trending and monitoring purposes.

• 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: kelly m. rackley ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22790314
• Report Number: 3006260740-2025-05753
• Device Sequence Number: 18208865
• Product Code: FOZ
• UDI-Device Identifier: 00801741140570
• UDI-Public: (01)00801741140570(11)250128(17)260131(10)REJY2536
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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
• Report Date (Section B): 09/15/2025

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 Expiration Date: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: F120088PT
• Device Lot Number: REJY2536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2025
• 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