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); Defective Component (2292)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that while placing the accucath and the patient was complaining of pain so she removed the accucath and there was a hole in the needle.
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and it will be evaluated.A supplemental will be submitted with evaluation results.
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 guidewire stuck in the flash notch of a needle is confirmed; however, the exact cause is unknown.One photograph of an accucath ace was returned for evaluation.An initial visual observation of the photograph showed the needle and guidewire were exposed and outside of the device housing.The guidewire was observed to be exiting the needle shaft at the flash notch.The coiled tip of the guidewire was observed to be damaged.The safety mechanism of the device was observed to have been activated, but the position of the guidewire appears to have prevented the full activation of the safety mechanism.Use residues were observed on the sample.While the guidewire of the device was observed to be positioned within the flash notch of the needle, there were no distinguishing features in the returned photograph of the device which could aid in identification of a specific root cause.This complaint will be recorded for future trending and monitoring purposes.

• 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: carey carter ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21601021
• Report Number: 3006260740-2025-01478
• Device Sequence Number: 17251044
• Product Code: FOZ
• UDI-Device Identifier: 00801741137945
• UDI-Public: (01)00801741137945(11)240608(17)250831(10)REJR3156
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/04/2025

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: 08/31/2025
• Device Model Number: N/A
• Device Catalogue Number: AC1182250
• Device Lot Number: REJR3156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2024
• 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