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

Model Number	0832F-00
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/31/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 2 UNIT RED CELL SET W/RC2H FIL
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 12595619
• Report Number: 1219343-2021-00134
• Device Sequence Number: 19964125
• Product Code: GKT
• UDI-Device Identifier: 10812747013512
• UDI-Public: (01)10812747013512(17)240204(10)0621053
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: BK060023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 02/24/2024
• Device Model Number: 0832F-00
• Device Lot Number: 0621053
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 10/08/2021
• 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