MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING

Model Number 442021

Device Problems Break (1069); Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) contamination was observed by the laboratory personnel.The customer stated results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: "the blood culture vial is contaminated with positive blood culture from a patient, with e.Coli bacteria found.".

Event Description

It was reported that while using bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) contamination was observed by the laboratory personnel.The customer stated results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: "the bloodculture vial is contaminated with positive blood culture from a patient, with e.Coli bacteria found.".

Manufacturer Narrative

H6: investigation summary customer reported contamination and damage bottle.Bd was not able to perform an investigation to the retention samples since batch number is unknown.A complaint history review cannot be conducted relating to the incident lot number and the ¿as reported¿ defect code since batch number is unknown.Complaints for reported catalog have been received.The batch history record could not be reviewed as the lot number is unknown nonetheless batch history records are always reviewed prior to product release.Product insert warnings and precautions sections states that prior to use, each vial should be examined for evidence of contamination such as cloudiness, bulging or depresses septum, or leakage.Vials showing evidence of contamination should not be used.Also prior to use, the user should examine the vial for evidence of damage or deterioration.Vials displaying turbidity, contamination, or discoloration (darkening) should not be used.Complaint is unconfirmed.No correctives actions were required.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process.H3 other text : see h10.

• Brand Name: BD BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• MDR Report Key: 12374607
• MDR Text Key: 268468918
• Report Number: 2647876-2021-00051
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420215
• UDI-Public: 00382904420215
• Combination Product (y/n): N
• PMA/PMN Number: K123903
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 442021
• Device Catalogue Number: 442021
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1