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

Model Number ACP KIT SERIES I

Device Problems Fluid/Blood Leak (1250); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2020

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 during a procedure, after the patient¿s blood was drawn, the clinical coordinator was inverting the plastic piece to apply the red stopper to the syringe, the inner syringe fell out of the unit.Some drops of blood splattered, and the syringe was not usable.Using a new kit and a new sample.Once it was spun down, as the surgeon attempted to draw off the top layer, the syringe would not allow it- it seems like the inner syringe to the second kit was not allowing the sample to pass through.

• 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: 10332277
• MDR Text Key: 200768435
• Report Number: 1220246-2020-01976
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: ACP KIT SERIES I
• Device Catalogue Number: ABS-10011
• Device Lot Number: 932599125
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/23/2019
• 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