MAUDE Adverse Event Report: HAEMONETICS CORP HAEMONETICS MCS+ 8150 APHERESIS SYSTEM; AUTOMATED BLOOD CELL SEPARATORS

Model Number	0832F-00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer discarded the kit and did not return it for the investigation.A lot history review was completed.This lot was manufactured according to approved procedures and met all specifications for release, with no noted manufacturing deviations or non-conforming events.The root cause of the reported complaint can't be determined.There is no sample or photo available to determine if there was a defect related to the manufacturing of the affected item or if user error was the cause of the issue.
Event or Problem Description
Haemonetics was notified on 02/09/2017 of a needlestick event that occurred with the collection set, (b)(4), filtered, utilized with a collection on the mcs+ 8150 apheresis system.The user was processing the collection set post donation and engaged the needle guard by pulling it.The user thought she heard the needle guard click and lock, but it had not locked and the user was stuck with the used needle.The user was seen at a local clinic and was given a tetanus shot as a precautionary measure.The user stated her last tetanus shot was seven years prior to this event.The user went back to the clinic for a follow up appointment one week later with no health issues.

• Brand Name: HAEMONETICS MCS+ 8150 APHERESIS SYSTEM
• Common Device Name: AUTOMATED BLOOD CELL SEPARATORS
• Manufacturer (Section D): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• MDR Report Key: 6391157
• Report Number: 1219343-2017-00005
• Device Sequence Number: 10958352
• Product Code: GKT
• UDI-Device Identifier: 10812747013512
• UDI-Public: (01)10812747013512(17)191027(10)1016036
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: BK060023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2017

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: Nurse
• Device Expiration Date: 10/27/2019
• Device Model Number: 0832F-00
• Device Catalogue Number: 0832F-00
• Device Lot Number: 1016036
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2017
• Initial Report FDA Received Date: 03/09/2017
• 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: Required Intervention
• Patient Age: 34 YR