MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH INTRAVASCULAR CATHETER 20GX2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer "accucath wire was reported stuck.More details needed to determine product or user error.No additional details received about procedure and occurrence".Additional information 12/20/222: product was used on the patient; patient had the guidewire and catheter stuck in her skin for close to 30 mins until provider was able to pull it out.Iv rn could not retract the wire.Relevant history, patient was considered difficult access.Patient did not have an infectious disease.
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by the customer "accucath wire was reported stuck.More details needed to determine product or user error.No additional details received about procedure and occurrence" additional information 12/20/222: product was used on the patient; patient had the guidewire and catheter stuck in her skin for close to 30 mins until provider was able to pull it out.Iv rn could not retract the wire.Relevant history, patient was considered difficult access.Patient did not have an infectious disease.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of guidewire immobility was confirmed.The product returned for evaluation was one 20ga x 2.25¿ accucath ace peripheral iv catheter assembly.Usage residues were observed throughout the sample.The catheter had been advanced and was not returned for evaluation.The guidewire was withdrawn into the housing.The wire exhibited permanent bends at the proximal end.The wire was not mobile within the needle shaft.The safety button was depressed; however, the needle was not withdrawn into the housing because of that immobility.Microscopic inspection of the needle revealed blood residue abundant within the shaft.The wire was visibly adhered to the needle at the blood flash notch.Guidewire mobility was re-established during gentle manipulation.The wire was intact; however, deformation was observed within the coil region.Blood residue was adhered to the guidewire.Blood product residue within the needle shaft appeared to cause the observed guidewire immobility.Such an event may occur if blood is allowed to coagulate within the needle shaft prior to guidewire advancement.The guidewire tip deformation suggested that attempted insertion against resistance, such as into tissue, may have contributed.

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER 20GX2.25
• 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: 16098539
• Report Number: 3006260740-2022-05979
• Device Sequence Number: 12441787
• Product Code: FOZ
• UDI-Device Identifier: 00801741111006
• UDI-Public: (01)00801741111006
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 02/24/2023

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: AC0202252
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2022
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/27/2023
• 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: Female