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

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
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 device has not been received by the manufacturer for evaluation.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.
Event or Problem Description
It was reported snagging guidewire - safety jammed(18g accucath).No patient harm.No further information was provided.
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 guidewire leading to the failure of the safety mechanism is confirmed and was determined to be use-related.One 18 ga accucath ace device was returned for evaluation.An initial visual observation of the returned device showed abundant blood residues throughout the device.The safety mechanism for sample 2 was engaged, but the needle was only partially retracted.The guidewire was observed to be broken and extended out of the needle shaft for sample 2.Functional testing of attempting to advance the guidewire for the returned device revealed the guidewire would not advance.Functional testing of attempting to get the needle to safety completely inside the housing of the device revealed sample 2 was able to safety completely inside the housing of the device with some manipulation.Microscopic observations of sample 2 revealed the distal end of the guidewire to be inside the distal end of the needle.Attempts to remove the distal end of the guidewire were unsuccessful, as a piece of the guidewire broke during an attempt to remove the distal end of the guidewire from the needle shaft.The break in the guidewire of sample 2 before lab manipulation showed a flat fracture surface.The needle tip of sample 2 was observed to be barbed.The cause of this failure was determined to be related to the abundant blood residues inside the device which caused difficulty advancing the guidewire and ultimately led to the failure of the safety mechanism.The safety mechanism will not engage if the guidewire cannot pass through the needle shaft.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: ACCUCATH ACE
• 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 sparks ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23816936
• Report Number: 3006260740-2025-09694
• Device Sequence Number: 9409751
• Product Code: FOZ
• UDI-Device Identifier: 00801741137945
• UDI-Public: (01)00801741137945(11)250709(17)260930(10)REKS2031
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K162894
• 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): 04/22/2026

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: 09/30/2026
• Device Model Number: N/A
• Device Catalogue Number: AC1182250
• Device Lot Number: REKS2031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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: Other
• Patient Sex: Unknown