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

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
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 will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported while trying to insert a 18g 10cm midline into the patient, the guidewire became stuck.Upon removing the needle/guidewire the guide wire ripped and pulled half mostly out.Upon removing the catheter, the rest of the guidewire appeared at the end of the catheter tip with bends/coils.Patient had to be stuck again.No harm to patient.
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 guidewire is confirmed and was determined to be use-related.One 18 ga powerglide pro was returned for evaluation.An initial visual observation of the returned device revealed the device was used and missing its catheter.The safety mechanism was engaged over the needle tip.The guidewire was broken, and the coil wire was observed to be unraveled and coming out of the distal tip of the needle.A microscopic observation of the powerglide pro showed the core wire just distal of the safety mechanism.The distal break site of the core wire appeared to have a slight bend as if it had been pulled against the needle bevel.The coil wire appeared to be stretched and unraveled.The break site of both the core wire and the coil wire appeared granular, and the fracture surfaces appeared to be broken at an angle.Pulling the guidewire back against the needle bevel of the device may cause the guidewire to break, as the guidewire gets caught along the needle bevel.Inspection of the returned device revealed no potential damage/defect related to the manufacture 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21651970
• Report Number: 3006260740-2025-01656
• Device Sequence Number: 7535789
• Product Code: FOZ
• UDI-Device Identifier: 00801741140556
• UDI-Public: (01)00801741140556(11)240909(17)250930(10)REJU2443
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 05/28/2025

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: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: F118088PT
• Device Lot Number: REJU2443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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: Other
• Patient Sex: Unknown