ANAEROBIC BLOOD CULTURE BOTTLE UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-12 for ANAEROBIC BLOOD CULTURE BOTTLE UNKNOWN manufactured by Difco Laboratories.

Event Text Entries

[19174277] A syringe with 20 cc of the pt's blood was attached to an anaerobic blood culture bottle. The syringe immediately emptied into the bottle. The bottle then forcefully broke into several pieces. Blood and glass sprayed onto the wall and the phlebotomy table. There was no injury or fluid exposure reported to the pt or the phlebotomist. The mfr was notified of the event, and all remaining blood culture bottles from that lot were returned.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 13933
• MDR Report Key: 13933
• Date Received: 1994-04-12
• Date of Report: 1994-04-11
• Date of Event: 1994-04-04
• Date Facility Aware: 1994-04-07
• Report Date: 1994-04-11
• Date Reported to FDA: 1994-04-11
• Date Added to Maude: 1994-06-14
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• 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: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ANAEROBIC BLOOD CULTURE BOTTLE
• Generic Name: ANAEROBIC BLOOD CULTURE BOTTLE
• Product Code: JSL
• Date Received: 1994-04-12
• Model Number: UNKNOWN
• Catalog Number: UNKNOWN
• Lot Number: 17488
• ID Number: NA
• Device Expiration Date: 1994-04-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 13931
• Manufacturer: DIFCO LABORATORIES
• Manufacturer Address: DETROIT MI 48232 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-04-12