MAUDE Adverse Event Report: ARTHREX, INC. ACP KIT SERIES I; SYRINGE, PISTON

Model Number ACP KIT SERIES I

Device Problem Burst Container or Vessel (1074)

Patient Problem Exposure to Body Fluids (1745)

Event Date 07/08/2022

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On (b)(6) 2022, it was reported by a facility representative via sems that an abs-10011 acp kit series i exploded during an unspecified procedure.The patient was not affected, another acp kit was used to complete the case.This was discovered during use with no impact to the patient.On 07/12/2022, the facility representative replied via email and provided the following information: this event occurred during a prp injection procedure to both knees on 06/30/2022.Anti-coagulant was not used, but air bubbles were observed during the blood draw.When the kit exploded, the nurses were exposed to bodily fluid.The area was decontaminated afterward and the surgeon, facility staff/nurses, and patient are all ok and fine to date.On 07/12/2022, the facility representative stated the following additional information over the phone: the bag with the blood just popped, and blood was everywhere, the nurses were drenched, no one panicked, and the patient was not affected.This happened when they were extracting, the nurses have done this procedure for a couple of years and this has never happened before.Everything was decontaminated, and a second bag was used to complete the procedure successfully.

• Brand Name: ACP KIT SERIES I
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 15093479
• MDR Text Key: 304797588
• Report Number: 1220246-2022-05290
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00888867001824
• UDI-Public: 00888867001824
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK070069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: ACP KIT SERIES I
• Device Catalogue Number: ABS-10011
• Device Lot Number: 2039119336
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2022
• Date Device Manufactured: 03/14/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1