MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MIDLINES, POLYURETHANE, ACCUCATH ACE, N/A; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
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 will be submitted with evaluation results.
Event or Problem Description
It was reported by the customer that "nurse attempted to place a accucath, however the wire threaded initially but the catheter would not advance.Nurse attempted to remove full device at one time but it would not come out.Despite needle retracting it was shown that the wire was not coming out under x ray." the guidewire did not break.Device removed by ir physician, added force.There was no delay and no harm.New catheter was placed in the other arm.
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 the cause appeared to be use-related.The product returned for evaluation was one 20ga x 2.25¿ accucath ace peripheral iv catheter assembly.The catheter was advanced and was received separated from the housing assembly.The safety button was pressed and the needle was fully withdrawn into the housing.Microscopic inspection of the guidewire revealed bending and kinking within the coil region.The guidewire was intact.Microscopic inspection of the catheter revealed deformation at the distal tip.The edges of the catheter were buckled and flared outward.Blood residue was visible on the guidewire ands throughout the catheter.The guidewire and catheter deformation were consistent with attempted insertion against resistance.Such resistance may occur if the insertion angle is too steep and if the catheter is pressed against the vessel wall of the target vein.

• Brand Name: MIDLINES, POLYURETHANE, ACCUCATH ACE, N/A
• 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: 22079297
• Report Number: 3006260740-2025-03337
• Device Sequence Number: 8702161
• Product Code: FOZ
• UDI-Device Identifier: 00801741138010
• UDI-Public: (01)00801741138010(11)241217(17)260331(10)REJY0357
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K162894
• 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): 07/11/2025

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: 03/31/2026
• Device Model Number: N/A
• Device Catalogue Number: AC1202252
• Device Lot Number: REJY0357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• 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