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

Model Number	N/A
Medical Device Problem Codes	Product Quality Problem (1506); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
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 that issues with needle retraction, leading to additional stick.The needle retraction failure was during patient use.The catheter would not advance and the catheter was removed from the patient.When the nurse pushed the button to retract, about 1cm of the needle would not retract back.
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 difficulty activating the safety mechanism is confirmed and was determined to be related to damage to the guidewire during use of the product.One 20 ga accucath ace was returned for evaluation.An initial visual observation of the returned device showed blood residues throughout the device.The safety mechanism button appeared to be engaged, but the needle was observed to be only partially retracted into the housing.A functional test of attempting to engage the safety mechanism completely involved manipulation of the guidewire and the needle.The needle retracted completely after manipulation of the device.A microscopic observation revealed no breaks or damage along the guidewire of the device.The guidewire was exiting the device through the flash notch along the needle shaft.Nothing remarkable was observed along the housing or safety mechanism of the device.This damage to the guidewire will prevent the safety mechanism from activating as intended.This failure may occur if there is a steep insertion angle and the device is not properly stabilized, resistance is met during advancement of the guidewire, or due to improper advancement and retraction of the guidewire during use of the product.A review of the manufacture quality and inspection records for the implicated product batch likewise indicated no potentially related issues related to product manufacture, assembly, and packaging.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: ACCUCATH ACE
• Common Device Name: ACUTE DIALYSIS 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23424608
• Report Number: 3006260740-2025-08201
• Device Sequence Number: 8253155
• Product Code: FOZ
• UDI-Device Identifier: 00801741138010
• UDI-Public: (01)00801741138010(11)250612(17)260930(10)REKR3628
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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): 01/16/2026

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: AC1202252
• Device Lot Number: REKR3628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• 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