MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS; SYSTEM, BLOOD CULTURING

Catalog Number	442288
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone #: (b)(6).Pma/510(k)# k970512, k970333.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd bactec¿ myco/f lytic culture vials they showed false negatives for hiv.This is a report of two occurrences.No false results were reported out to the clinician or the patient.The following information was provided by the initial reporter: they are reporting a query or potentially an issue identified with use of the myco f lytic bottle 442288 for a hiv positive patient.Essentially the patient sample had one bottle removed in error earlier than the protocol (42 days) as negative and the second bottle was then removed @ 43.5 days also as negative.Because one bottle had been removed early they did a terminal auramine test and it was positive.They sent the samples to st.James hospital dublin and while intermittent for whatever primary test method used i believe, st.James eventually reported both bottles as positive for mycobacterium genavense (m.Genavense).
Additional Manufacturer Narrative
The following fields were updated: b5.It was reported that while using bd bactec¿ myco/f lytic culture vials they showed false negatives for hiv.This is a report of two occurrences.No false results were reported out to the clinician or the patient.The following information was provided by the initial reporter: they are reporting a query or potentially an issue identified with use of the myco f lytic bottle 442288 for a hiv positive patient.Essentially the patient sample had one bottle removed in error earlier than the protocol (42 days) as negative and the second bottle was then removed @ 43.5 days also as negative.Because one bottle had been removed early they did a terminal auramine test and it was positive.They sent the samples to (b)(6) hospital and while intermittent for whatever primary test method used i believe, (b)(6) eventually reported both bottles as positive for mycobacterium genavense (m.Genavense).The bottles were loaded in march so the bottles were not expired at the time of use.H6.Investigation summary: catalog 442288.Batch no.1188588 expired.Customer reported a false negative result.Neither photos nor returned good samples were received.Upon further evaluation it was noticed that complaint received was from a product already expired.No investigation can be conducted to the retention samples since its past its expiry date.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.The batch history record could not be reviewed since the lot is expired, 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.The specimen must be collected using sterile techniques to reduce the chance of contamination.Quality control requirements must be performed in accordance with applicable local, state and/or federal regulations or accreditation requirements and laboratory¿s standard quality control procedures.It is recommended that the user refer to pertinent clsi guidance and clia regulations for appropriate quality control practices.Do not use culture vials past their expiration date.Do not use culture vials that exhibit any cracks or defects; discard the vial in the appropriate manner.The plots did not show any unusual characteristics or indicate a problem with the media or instrument.Complaint is unconfirmed.No corrective 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 investigational process.
Event or Problem Description
It was reported that while using bd bactec¿ myco/f lytic culture vials they showed false negatives for hiv.This is a report of two occurrences.No false results were reported out to the clinician or the patient.The following information was provided by the initial reporter: they are reporting a query or potentially an issue identified with use of the myco f lytic bottle 442288 for a hiv positive patient.Essentially the patient sample had one bottle removed in error earlier than the protocol (42 days) as negative and the second bottle was then removed @ 43.5 days also as negative.Because one bottle had been removed early they did a terminal auramine test and it was positive.They sent the samples to (b)(6) hospital and while intermittent for whatever primary test method used i believe, (b)(6) eventually reported both bottles as positive for mycobacterium genavense (m.Genavense).The bottles were loaded in march so the bottles were not expired at the time of use.

• Brand Name: BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
• 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: 14962289
• Report Number: 2647876-2022-00169
• Device Sequence Number: 5395417
• Product Code: MDB
• UDI-Device Identifier: 00382904422882
• UDI-Public: 382904422882
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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: 04/30/2022
• Device Catalogue Number: 442288
• Device Lot Number: 1188588
• 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: 06/08/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• 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