MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH 18GX2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
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.
Event or Problem Description
It was reported accucath catheter was d/c from patients arm and the coiled tip wire was still in catheter.Accucath was first placed in (b)(6) so wire was in catheter for almost 5 days.No intervention was needed.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 a break in the guidewire is confirmed and was determined to be use-related.One 18 ga accucath ace guidewire and catheter were returned for evaluation.An initial visual observation of the returned product revealed abundant blood use residues along the returned catheter.Some blood use residues were observed along the guidewire.The guidewire appeared to be intentionally cut from the housing of the device.A coil was observed at the distal end of the guidewire during an initial visual observation of the device.A microscopic observation of the returned guidewire revealed some of the coil at the distal end of the wire was missing from the device.The break site at the distal end of the guidewire appeared granular.An attempt to extract any guidewire material from the catheter revealed no guidewire material could be found in the returned catheter.Blood use residues were pushed through the catheter.Characteristics of the break site at the distal end of the guidewire revealed a break caused by pulling against a sharp instrument such as a needle bevel.Pulling the catheter and guidewire back against the needle bevel may result in a break in the guidewire or catheter.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported per medwatch, present on admissions peripheral intravenous line in left upper arm appeared to be leaking and possibly infiltrated.Ultrasound put to arm by rn to see if vein was still patent or if the line had infiltrated; while dot present throughout the vessel when scanning - line removed, and guidewire still present in accucath catheter (curled tip intact).Catheter placed 09/25.No intervention was needed.No other information was provided.

• Brand Name: ACCUCATH 18GX2.25
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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 garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20530345
• Report Number: 3006260740-2024-06182
• Device Sequence Number: 8465423
• Product Code: FOZ
• UDI-Device Identifier: 00801741110993
• UDI-Public: (01)00801741110993
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

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 Model Number: N/A
• Device Catalogue Number: AC0182252
• Device Lot Number: UNKNOWN
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian