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

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
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 returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by the customer that needle did not retract when activated by push button safety mechanism.No adverse or serious injury was reported to the patient or the healthcare professional.No other information was provided.
Event or Problem Description
It was reported by the customer that needle did not retract when activated by push button safety mechanism.No adverse or serious injury was reported to the patient or the healthcare professional.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 needle retraction failure was confirmed.The product returned for evaluation was one 18g accucath device.A gross visual inspection of the returned unit found that the needle was not retracted despite the button being in a pressed state.The guidewire was withdrawn into the housing and the guidewire tip was confirmed to be inside the needle.The guidewire was attempted to be advanced, however a large amount of resistance was encountered and the guidewire was unable to be moved.Microscopic inspection of the device found that a large amount of blood residue was present at the notch.The unit was dissected and the guidewire assembly forcibly removed.The guidewire was able to be removed without breaking the guidewire.The guidewire was then attempted to be re-threaded through the needle.However, resistance was encountered at the proximal end of the needle such that it could not be advanced any further.A cross section of the needle was taken at this location.Inspection of the cross section found that a mass of biological material was present, obstructing the path.It is likely that the presence of coagulated blood prevented the guidewire from sliding through the needle shaft and consequently prevented the needle from retracting.

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20490076
• Report Number: 3006260740-2024-06048
• Device Sequence Number: 11788604
• Product Code: FOZ
• UDI-Device Identifier: 00801741110993
• UDI-Public: (01)00801741110993
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• 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): 02/11/2025

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: 09/24/2024
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 10/20/2024
• Supplement Report FDA Received Date: 02/20/2025
• 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 Sex: Unknown