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	Component Incompatible (1108); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
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 the guidewire came out of the side needle notch.This occurred during training using a vein block, not on a patient.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.The complaint of improper guidewire advancement is confirmed and was determined to be use-related.One 18ga accucath ace was returned for evaluation.An initial visual observation revealed use residue on the sample.The guidewire was observed to be protruding from the needle flash notch.The guidewire coiled tip was observed to be broken and missing a small section of the tip.A microscopic observation revealed the broken guidewire coiled tip appeared to have a mostly flat and granular fracture surface, and the guidewire was observed to curve and taper near the break, indicating a tensile break occurred.No obvious damage was observed on the needle bevel or the flash notch.The investigation findings suggest the guidewire encountered resistance during insertion, causing the guidewire to fail to advance.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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22070684
• Report Number: 3006260740-2025-03302
• Device Sequence Number: 8600460
• Product Code: FOZ
• UDI-Device Identifier: 00801741138003
• UDI-Public: (01)00801741138003(11)241128(17)251130(10)REJX0865
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/15/2025

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: 11/30/2025
• Device Model Number: N/A
• Device Catalogue Number: AC1182252
• Device Lot Number: REJX0865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• 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