MAUDE Adverse Event Report: ARTHREX, INC. BIOSURGE KIT WITH 5.0CC ALLOSYNC PURE; PLATELET AND PLASMA SEPARATOR

Model Number	BIOSURGE KIT WITH 5.0CC ALLOSYNC PURE
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that an abs-2016-02 biosurge kit with 5.0cc allosync pure had a hole in the tubing preventing them from being able to use that kit with the angel machine.The kit was discarded because it contained the patient's blood.No negative outcome was associated with the event.This occurred during use with no patient harm.Additional information has been requested.
Event or Problem Description
Additional information: this occurred during an unspecified clinical procedure with anesthesia.There was no leakage until they squeezed on the bag.The hole was near the rotor.The site was decontaminated per the standard decontamination protocol.The surgery was completed successfully; however, as the abs-2016-02 biosurge kit could not be used, the procedure could not be augmented.It was a very minimal deviation from the intended procedure with no adverse effects for the patient.
Additional Manufacturer Narrative
Additional information: b5, g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.

• Brand Name: BIOSURGE KIT WITH 5.0CC ALLOSYNC PURE
• Common Device Name: PLATELET AND PLASMA SEPARATOR
• 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: emily shafer ; 8009337001
• MDR Report Key: 17698010
• Report Number: 1220246-2023-07799
• Device Sequence Number: 15303615
• Product Code: ORG
• UDI-Device Identifier: 00888867319943
• UDI-Public: 00888867319943
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: BK180180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: BIOSURGE KIT WITH 5.0CC ALLOSYNC PURE
• Device Catalogue Number: ABS-2016-02
• Device Lot Number: 220520805
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown