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

Model Number ACP KIT SERIES I

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 04/02/2020

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 syringe¿s seal on the abs-10011, acp kit series i was not working properly and it was leaking so another kit had to be opened. Additional information has been requested. Additional information received on 4/24/2020: the rep reported the malfunction occurred during an inclinc acp injection for oa. The issue occurred during the preparation portion of the case, while separating the plasma from the rest of the blood. It was reported that blood did leak outside of the syringe, and came into contact with the nurse. The device and surfaces were cleaned using disinfecting wipes. The device was discarded, and a second abs-10011 was opened and blood draw was done again. The sales rep reported that the facility does have the latest user manual for appropriate cleaning of blood spills.

• 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: 10055675
• Report Number: 1220246-2020-01836
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00888867001824
• UDI-Public: 00888867001824
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BK070069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 07/31/2021
• Device Model Number: ACP KIT SERIES I
• Device Catalogue Number: ABS-10011
• Device Lot Number: 920695773
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/24/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/19/2019
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial
• Patient Outcome(s): Other