MAUDE Adverse Event Report: ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refq1275 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "coiled tip of the wire broke off while attempting to place the iv.Wire remained in patient.Nurse said insertion was normal with no resistance but would not thread nor safety when trying to advance the catheter and activate the safety.".
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, complaint and lot history review, applicable previous investigation(s), applicable fmea documents, labeling, evaluation of the returned sample, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint that the accucath wire broke during insertion was inconclusive due to the state of the returned sample.A full-sized sharps container was returned with several items contained within the container.An accucath delivery mechanism and catheter were seen within the container and the catheter appeared to be severely damaged.It appeared that the guidewire extended from the distal end of the delivery system but the condition of the guidewire tip could not be discerned due to the condition of the returned sample.Further review of the sample was not selected as the implicated accucath sample was surrounded by other exposed sharps and broken glass within a used sharps container.A potential cause is advancement/retraction of the guidewire against resistance and damage caused by the needle bevel during manipulation of the device; however, confirmation of the reported failure and assessment of the actual root cause was complicated by the state of the returned sample.
Event or Problem Description
It was reported "coiled tip of the wire broke off while attempting to place the iv.Wire remained in patient.Nurse said insertion was normal with no resistance but would not thread nor safety when trying to advance the catheter and activate the safety." it was reported via medwatch "while inserting an ultrasound guided iv into the right arm, the tip of the accucath guidewire broke off into the patient, confirmed by x-ray and inspection of the device.".

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 12253718
• Report Number: 3006260740-2021-03042
• Device Sequence Number: 17266905
• Product Code: FOZ
• UDI-Device Identifier: 00801741110948
• UDI-Public: (01)00801741110948
• 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
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AC0202250
• Device Lot Number: REFQ1275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 09/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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: Required Intervention