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

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer, "powerglide guidewire stick after it was engaged.I followed the needle tip all the way in.The needle encasement did come apart during insertion.I engaged the guidewire without difficulty.I attempted to advance the catheter and it would not move at all.I then attempted to pull the guidewire back in and it would not move.I removed the unit as 1 piece." additional information 7/30/2025: it was reported the patient had to be stuck an additional time.1/27/2025 - during evaluation of the returned device, the guidewire was found to have misaligned coils.
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 difficult catheter insertion was confirmed and was determined to be use related.The product returned for evaluation was a 18ga x 8cm powerglide pro midline catheter assembly.Usage residues were observed on the sample.The device was received fully assembled and the guidewire was fully advanced.A permanent bend was observed in the guidewire at the exit site from the needle.Microscopic inspection of the distal end of the catheter revealed it was deformed and flared outward.Microscopic inspection of the guidewire revealed a misaligned coil in the vicinity of the bend.The bend in the guidewire and catheter deformation were consistent with attempted insertion at a steep angle or insertion against resistance.The biological residue suggested the damage occurred during attempted device placement.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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21453077
• Report Number: 3006260740-2025-00942
• Device Sequence Number: 7290427
• Product Code: FOZ
• UDI-Device Identifier: 00801741140600
• UDI-Public: (01)00801741140600(11)240312(17)250331(10)REJN2295
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 02/21/2025

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: 03/31/2025
• Device Model Number: N/A
• Device Catalogue Number: F218088PT
• Device Lot Number: REJN2295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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