MAUDE Adverse Event Report: HAEMONETICS CORPORATION 2 UNIT RED CELL SET W/RC2H FIL

Model Number	2 UNIT RED CELL SET W/RC2H FIL
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A blood sample of the employee was taken as well as a sample of the donors' blood for an infectious disease panel to be conducted.Investigation identified evidence that the bowl connector was not completely inserted into the bowl port, and was confirmed per marks presented on blue bowl connector.These marks are produced during sterilization of the disposable and remain permanent until heat is applied to plastic.
Event or Problem Description
On (b)(6) 2020, haemonetics was informed by the customer that after the donation an employee was trying to remove the kit and the connector disconnected and sprayed blood in the employee's eye.

• Brand Name: 2 UNIT RED CELL SET W/RC2H FIL
• Common Device Name: 2 UNIT RED CELL SET W/RC2H FIL
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• MDR Report Key: 9788060
• Report Number: 1219343-2020-00011
• Device Sequence Number: 14115974
• Product Code: GKT
• UDI-Device Identifier: 10812747013512
• UDI-Public: (01)10812747013512(17)220918(10)0919008
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: BK060023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/04/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2 UNIT RED CELL SET W/RC2H FIL
• Device Catalogue Number: 0832F-00
• Device Lot Number: 0919008
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other