MAUDE Adverse Event Report: GREINER BIO-ONE GMBH VACUETTE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	450241
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Vacuette broke off at the area used to connect to a syringe or butterfly needle.

• Brand Name: VACUETTE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): GREINER BIO-ONE GMBH; 4238 capital dr; monroe NC 28110
• MDR Report Key: 13280349
• Report Number: 13280349
• Device Sequence Number: 14690272
• Product Code: FMI
• UDI-Device Identifier: 29120049200232
• UDI-Public: (01)29120049200232
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/03/2021
• Report Date (Section F): 12/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 450241
• Device Catalogue Number: 450241
• Device Lot Number: A2101464
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/03/2021