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

Model Number 0832F-00

Device Problem Insufficient Information (3190)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/31/2021

Event Type  Injury  

Manufacturer Narrative

There was no donor impact.Although there was exposure to the needle, the operator was wearing ppe at the time of incident.The operator was sent for blood work but the results are confidential.Sample was discarded.The root cause of the reported complaint cannot be determined as it is not possible without a photo and or physical sample for evaluation.

Event Description

On (b)(6) 2021 haemonetics was notified of a needle stick due to a needle guard malfunction which occured post procedure to the operator when disconnecting donor , utilizing a 2 unit red cell set.

• 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 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: janice kiser ; 125 summer street; boston, MA 02110
• MDR Report Key: 12595619
• MDR Text Key: 279603920
• Report Number: 1219343-2021-00134
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 10812747013512
• UDI-Public: (01)10812747013512(17)240204(10)0621053
• 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: 09/07/2021

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: 02/24/2024
• Device Model Number: 0832F-00
• Device Lot Number: 0621053
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2021
• Initial Date FDA Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other