MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BBL¿ VDRL ANTIGEN; SYSTEM, BLOOD CULTURING

Model Number	442194
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd bbl¿ vdrl antigen there was contamination; biological contamination, bacterial, fungal, non viable.The following information was provided by the initial reporter.The customer stated: there was possible contamination with bactec 442194 bottle.The bottle grew the same organism which was not expected.They had an additional 6 bottles tests from the same lot number but none of them were positive for the bacteria isolated from the other two bottles.Customer did not provide the isolate name.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd bbl¿ vdrl antigen there was contamination; biological contamination, bacterial, fungal, non viable.The following information was provided by the initial reporter.The customer stated: there was possible contamination with bactec 442194 bottle.The bottle grew the same organism which was not expected.They had an additional 6 bottles tests from the same lot number but none of them were positive for the bacteria isolated from the other two bottles.Customer did not provide the isolate name.
Additional Manufacturer Narrative
Investigation summary: bd was unable to reproduce the customer¿s experience with the bactec.Retention samples were visually inspected, tested for viable contamination by sub-culturing on tsa, chocolate, sabouraud and schaedler agars plates, voltage output and gram stain.All results were satisfactory.Batch history record review did not identify any evidence for which the customer submitted the complaint.A complaint history review was conducted and only the current complaint was found relating to the incident lot number and the ¿as reported¿ defect code.Complaint is unconfirmed based on retention samples and batch history record review.

• Brand Name: BD BBL¿ VDRL ANTIGEN
• Common Device Name: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13641024
• Report Number: 2647876-2022-00037
• Device Sequence Number: 16700669
• Product Code: MDB
• UDI-Device Identifier: 00382904421946
• UDI-Public: 00382904421946
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K954927
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2022
• Device Model Number: 442194
• Device Catalogue Number: 442194
• Device Lot Number: 1259101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown