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	10/01/2025
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 needle won't retract.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, and the guidewire was coming out of the flash notch of the needle shaft.The safety mechanism for sample 3 was engaged, but the needle was only partially retracted.The guidewire for sample 3 was coming out of the flash notch of the device and was looped back into the flash notch of the device.Functional testing of attempting to advance the guidewire for the returned device revealed the guidewire would not advance.Sample 3 was unable to allow the needle to safety completely.Microscopic observations of sample 3 revealed blood residues occluding the flash notch and distal end of the needle shaft.An attempt to pull the loop guidewire gently out of the flash notch was successful; however, the guidewire appeared broken upon pulling it out of the flash notch.It could not be determined whether the guidewire broke during the investigation of the device or during use of the device.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: 23817291
• Report Number: 3006260740-2025-09697
• Device Sequence Number: 10098761
• Product Code: FOZ
• UDI-Device Identifier: 00801741137945
• UDI-Public: (01)00801741137945(11)250802(17)261031(10)REKT1395
• 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 Model Number: N/A
• Device Catalogue Number: AC1182250
• Device Lot Number: REKT1395
• 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: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2025
• 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