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

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reeq4025 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch "guidewire appears to be stuck.Unable to retract needle and push guidewire in." original procedure: "insertion of ultrasound guided intravenous needle into a difficult access patient.".
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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a stuck guidewire was confirmed.The product returned for evaluation was one 18ga x 2.25¿ accucath peripheral iv catheter assembly.Usage residues were observed throughout the sample.Blood residue was abundant within the needle shaft.The wire was fully withdrawn into the housing.The safety button was depressed; however, the needle was not withdrawn into the housing.Microscopic inspection of the sample confirmed blood residue within the needle shaft, which appeared to be bonding the wire to the needle.Attempts to advance the wire were unsuccessful.The wire was not mobile within the needle.The observed inability to advance the guidewire appeared to be caused by blood product coagulation within the needle shaft.This can occur if blood is allowed to coagulate within the device prior to guidewire advancement.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported via medwatch "guidewire appears to be stuck.Unable to retract needle and push guidewire in." original procedure: "insertion of ultrasound guided intravenous needle into a difficult access patient.".

• Brand Name: ACCUCATH, 18 GX2.25
• 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
• MDR Report Key: 10659002
• Report Number: 3006260740-2020-20037
• Device Sequence Number: 19794620
• Product Code: FOZ
• UDI-Device Identifier: 00801741110931
• UDI-Public: (01)00801741110931
• 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
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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: AC0182250
• Device Lot Number: REEQ4025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 12/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other