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

Model Number 0832F-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/07/2017

Event Type  Injury  

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 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
• Type of Device: AUTOMATED BLOOD CELL SEPARATORS
• Manufacturer (Section D): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer (Section G): HAEMONETICS MEXICO MANUFACTURING, S. DE R.L. DE C.; calle colinas no. 11731 secc.; industrial el florido; tijuana, mexico 22244 ; MX 22244
• Manufacturer Contact: julie smith, rn ; 400 wood rd; braintree, MA 02184
• MDR Report Key: 6391157
• MDR Text Key: 69483618
• Report Number: 1219343-2017-00005
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 10812747013512
• UDI-Public: (01)10812747013512(17)191027(10)1016036
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/09/2017
• Initial Date FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR