BD VACUTAINER? NO ADDITIVE (Z) TUBES 366703

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-24 for BD VACUTAINER? NO ADDITIVE (Z) TUBES 366703 manufactured by Becton, Dickinson & Co. (broken Bow).

MAUDE Entry Details

• Report Number: 1917413-2019-02122
• MDR Report Key: 9112445
• Date Received: 2019-09-24
• Date of Report: 2019-10-02
• Date of Event: 2019-09-03
• Date Mfgr Received: 2019-09-04
• Device Manufacturer Date: 2018-06-05
• Date Added to Maude: 2019-09-24
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: BDX BRETT WILKO
• Manufacturer Street: 9450 SOUTH STATE STREET
• Manufacturer City: SANDY UT 84070
• Manufacturer Country: US
• Manufacturer Postal: 84070
• Manufacturer Phone: 8015652341
• Manufacturer G1: BECTON, DICKINSON & CO. (BROKEN BOW)
• Manufacturer Street: 150 SOUTH 1ST AVENUE
• Manufacturer City: BROKEN BOW NE 68822
• Manufacturer Country: US
• Manufacturer Postal Code: 68822
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BD VACUTAINER? NO ADDITIVE (Z) TUBES
• Generic Name: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Product Code: FMH
• Date Received: 2019-09-24
• Returned To Mfg: 2019-09-17
• Catalog Number: 366703
• Lot Number: 8156805
• Device Expiration Date: 2019-11-30
• Device Availability: R
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BECTON, DICKINSON & CO. (BROKEN BOW)
• Manufacturer Address: 150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-09-24