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); Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2025
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 accucath was inserted and guidewire was advanced.Catheter was then advanced and needle retracted.The guidewire would not retract and there was resistance.Catheter was manipulated slightly and a popping sound was heard and the entire device was removed.Patient had to receive an ultrasound, an xray of the arm and a cta to rule out foreign body retainment.No other 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.
Event or Problem Description
Additional information received on 23-dec-2025.We did not see evidence that a piece was retained in the patient after cta.There were no radiopaque pieces noted.Thus, there was no interventions.
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 guidewire retraction was confirmed but the cause is unknown.A single photograph of two accucath ace deployment devices was returned for evaluation.It was reported that one of the devices was an unused comparison sample while the other was the implicated product.The catheter had been deployed off of both devices and the needle had been retracted.The guidewire was seen protruding from the handle on both samples.The non-complainant sample appeared unremarkable to gross visual observation.The guidewire on the used sample appeared to contain a bent shape memory.In addition, the coiled tip was detached from the guidewire.The distal end of the guidewire appeared to taper down in diameter, indicative of a guidewire fracture.The detached fragment of coiled guidewire was not visible in the returned photograph.The photograph supported the reported event of difficult guidewire removal.The difficult removal was likely a contributing factor of the break in the wire.However, the exact cause of the initial difficulty could not be determined from the returned photograph; there were no distinguishing features which could aid in identification of a specific root cause.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: 23851492
• Report Number: 3006260740-2025-09894
• Device Sequence Number: 9571825
• Product Code: FOZ
• UDI-Device Identifier: 00801741137952
• UDI-Public: (01)00801741137952(11)250705(17)260930(10)REKS2052
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 02/20/2026

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: AC1202250
• Device Lot Number: REKS2052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 12/23/2025; 02/19/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/21/2026; 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2025
• 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