FDA Adverse Event Other Summary report: N

BACTEC LYTIC/10 ANAEROBIC/F MEDIUM

MDR report key: 1378317 · Received May 8, 2009

Report

Report Number: 1119779-2009-00006
Event Type: Other
Date Received: May 8, 2009
Date of Event: April 24, 2009
Report Date: May 7, 2009
Manufacturer: BD CARIBE, LTD.
Product Code: JSL
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ALTHOUGH THE TECHNICIAN WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AND WAS USING FORCEPS, SHE WAS STILL PIERCED BY THE BROKEN GLASS. SHE RECEIVED A TETANUS AND ANTIBIOTICS. NO INVESTIGATION REGARDING THE BOTTLE COULD BE CONDUCTED DUE TO THE INABILITY TO RETRIEVE A LOT NUMBER OF THE BROKEN BACTEC BLOOD CULTURE VIAL. NO RETURNS ARE RECEIVED DUE TO THE NATURE OF THE COMPLAINT. BD WILL CONTINUE TO EDUCATE THE CUSTOMER CONCERNING PROPER HANDLING OF BACTEC BOTTLES AND ANY BREAKAGE THAT MAY OCCUR. BD WILL CONTINUE TO CLOSELY MONITOR THIS TYPE OF ISSUE.

Description of Event or Problem · 1

A POSITIVE BLOOD CULTURE VIAL WAS BROKEN DURING REMOVAL FROM THE HOSPITAL'S BACTEC INSTRUMENT. ALTHOUGH THE TECHNICIAN WAS USING FORCEPS TO REMOVE THE GLASS PIECES FROM THE INSTRUMENT, A SMALL GLASS PIECE PUNCTURED HER GLOVE AND PIERCED HER FINGER. THE TECHNICIAN WAS REFERRED TO THE HOSPITAL NURSE FOR TREATMENT. SHE RECEIVED A TETANUS SHOT AND WAS PRESCRIBED ANTIBIOTICS AS PROPHYLAXIS DUE TO THE POSITIVITY OF THE CULTURE. AT A LATER DATE THE ANTIBIOTIC WAS CHANGED DUE TO THE ORGANISM BEING RESISTANT TO THE ANTIBIOTIC ORIGINALLY PRESCRIBED. THE TECH DID NOT HAVE AN IDENTIFICATION FOR THE ORGANISM THAT WAS ISOLATED FROM THE BLOOD CULTURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	BACTEC LYTIC/10 ANAEROBIC/F MEDIUM		JSL	BD CARIBE, LTD.		UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other