BACTECNR6 BLOOD CULTURE MEDIUM 4404391

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 1997-03-27 for BACTECNR6 BLOOD CULTURE MEDIUM 4404391 manufactured by Becton Dickinson Microbiology Systems.

Event Text Entries

[16300929] An unk customer was inoculating a blood culture vial and felt that the stopper was hard to penetrate. The piston of the syringe jumped and the user had some blood splatter in face and eyes. Several attempts have been made by phone, written, and electronic communication to identify the customer, the event date, any medical treatment and the lot number affected. All have been unsuccessful. There is no indication that the user has had any medical problems since the event.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1119779-1997-00001
• MDR Report Key: 80851
• Report Source: 01,06
• Date Received: 1997-03-27
• Date of Report: 1997-03-17
• Date Mfgr Received: 1996-12-10
• Date Added to Maude: 1997-04-04
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BACTECNR6 BLOOD CULTURE MEDIUM
• Generic Name: CULTURE MEDIA
• Product Code: JSC
• Date Received: 1997-03-27
• Model Number: NA
• Catalog Number: 4404391
• Lot Number: UNK
• ID Number: NA
• Operator: OTHER
• Device Availability: N
• Device Age: UNKNOWN
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 80309
• Manufacturer: BECTON DICKINSON MICROBIOLOGY SYSTEMS
• Manufacturer Address: 7 LOVETON CIRCLE SPARKS MD 21152 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-03-27