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

Model Number 0832F-00

Device Problem Mechanical Jam (2983)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/06/2021

Event Type  Injury  

Manufacturer Narrative

On may 17, 2021 the sample was received by haemonetics for evaluation.A visual evaluation was conducted and plastic residue was identified on the lower end of the needle guard thus not allowing it to lock the needle into place.As the evaluation is still ongoing the root cause has yet to be determined.

Event Description

On may 06, 2021 haemonetics was notified of a needle guard that did not lock needle after disconnect resulting in an accidental needle stick which was observed post procedure, utilizing a 2 unit red cell set.The exposure status of patient and operator is currently unknown.

Manufacturer Narrative

This need stick incident occurred while operator was disconnecting the donor once donation procedure was completed.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.Haemonetics received returned sample for evaluation and was not able to confirm the reported defect.A visual evaluation was conducted and a cosmetic flash was identified on the lower end of the needle guard.The flash that was identified on the end of the guard did not interfere with the needle guard's function.The needle guard functioned as intended when the mechanism was on.Dhr review indicated that the lot was manufactured according to approved procedures and met all specifications for release.Based on the complaint sample evaluation it has been determined that the product was working as expected.

• 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
• MDR Report Key: 11942281
• MDR Text Key: 258358238
• Report Number: 1219343-2021-00028
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 10812747013512
• UDI-Public: (01)10812747013512(17)240204(10)0221026
• Combination Product (y/n): N
• PMA/PMN Number: BK060023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

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: 0221026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/04/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other