MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ACP DOUBLE SYRINGE SYSTEM; SYRINGE, PISTON

Model Number ARTHREX ACP DOUBLE SYRINGE SYSTEM

Device Problems Fluid/Blood Leak (1250); Explosion (4006)

Patient Problem Exposure to Body Fluids (1745)

Event Date 06/15/2020

Event Type  Injury  

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.

Event Description

It was reported that the blood draw was being done using an abs-10010s, acp double syringe system.The kit exploded over the doctor, patient and the room.It was cleaned up and the doctor repeated the process.(b)(6) year old patient.Additional information obtained 6/18/2020: when the surgeon was conducting the procedure the inner syringe plunger was pushed out from the pressure inside and the patient's blood went all over the room.It was on the floor, walls, the surgeon's clothing, shoes, and on the patient as well.The office had to complete the procedure using another kit.The room was then closed for the remainder of the day while the blood spill was cleaned per blood borne pathogen cleaning process.The device was discarded due to blood exposure.

• Brand Name: ARTHREX ACP DOUBLE SYRINGE SYSTEM
• 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: 10217789
• MDR Text Key: 197300802
• Report Number: 1220246-2020-01933
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00888867083790
• UDI-Public: 00888867083790
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/30/2023
• Device Model Number: ARTHREX ACP DOUBLE SYRINGE SYSTEM
• Device Catalogue Number: ABS-10010S
• Device Lot Number: 918695225
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other