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

Model Number 2 UNIT RED CELL SET W/RC2H FIL

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/04/2020

Event Type  Injury  

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 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
• Type of Device: 2 UNIT RED CELL SET W/RC2H FIL
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer Contact: shaun flanagan ; 125 summer street; boston, ma
• MDR Report Key: 9788060
• MDR Text Key: 182470365
• Report Number: 1219343-2020-00011
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 10812747013512
• UDI-Public: (01)10812747013512(17)220918(10)0919008
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK060023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 2 UNIT RED CELL SET W/RC2H FIL
• Device Catalogue Number: 0832F-00
• Device Lot Number: 0919008
• Initial Date Manufacturer Received: 02/04/2020
• Initial Date FDA Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other