MAUDE Adverse Event Report: COMBAT MEDICAL SYSTEMS LLC FRESH WHOLE BLOOD TRANSFUSION SET; CONVENIENCE KIT

Model Number	2
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This was identified at a training operation within the us military.No patient involvement.Initial mdr assessment was completed and determined not to be reportable based on customer usage (training exercise) and no patient impact.However, a field action was initiated and in an abundance of caution we reevaluated our mdr assessment and are filing this report.Combat medical received a complaint that the blood pack needles were found bent upon opening the convenience kit.The issue was discovered to be one component (a stand alone device) within the convenience kit: blood pack, single unit, r80-808.Investigation has shown that the current assembly process has the potential of bending/disconnecting the needles used in the affected kits.The influence of the variation of the needle position within the component (blood pack, single unit, 450 ml (r80-808)), coupled with the manual assembly process of folding the blood pack is causing needle damage in the finished product.
Event or Problem Description
Needles in the donor kits are bent and one disconnected from the bag when the corpsman attempted to uncap the needle during a training exercise.

• Brand Name: FRESH WHOLE BLOOD TRANSFUSION SET
• Common Device Name: CONVENIENCE KIT
• Manufacturer (Section D): COMBAT MEDICAL SYSTEMS LLC; 5555 harrisburg indust park dr; harrisburg NC 28075
• MDR Report Key: 11158710
• Report Number: 3008258694-2021-00001
• Device Sequence Number: 3726627
• Product Code: POQ
• UDI-Device Identifier: M68980801020
• UDI-Public: M68980801020
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 01/12/2021

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: 01/31/2021
• Device Model Number: 2
• Device Catalogue Number: 80-801
• Device Lot Number: MFG3302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 300825869422DEC2020R001
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other