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

Model Number ACP KIT SERIES I

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problem Exposure to Body Fluids (1745)

Event Date 11/20/2019

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 by the materials department, that while prepping for a in clinic prp shoulder injection, after the spin, the syringe on the abs-10011, kit came off.The blood spilled onto the floor, counter and physicians assistants foot.It was reported by the caller, that all the blood was cleaned and sanitized per protocol.The prp injection was completed using a different abs-10011, kit and additional blood draw.

• 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: 9446171
• MDR Text Key: 184818852
• Report Number: 1220246-2019-01474
• 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: health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: ACP KIT SERIES I
• Device Catalogue Number: ABS-10011
• Device Lot Number: 916294493
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/05/2019
• 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