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

Model Number	442027
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: 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 while testing with bd bactec¿ standard/10 aerobic/f culture vials (plastic) a false positive result was obtained.There was no indication that results were reported out, and there was no report of patient impact.The following information was provided by the initial reporter: customer reports that he obtained a false positive result on an apheresis bag during a bactec fx equipment verification procedure.
Event or Problem Description
It was reported while testing with bd bactec¿ standard/10 aerobic/f culture vials (plastic) a false positive result was obtained.There was no indication that results were reported out, and there was no report of patient impact.The following information was provided by the initial reporter: customer reports that he obtained a false positive result on an apheresis bag during a bactec fx equipment verification procedure.
Additional Manufacturer Narrative
H.6 investigation summary: catalog 442027 batch no.1245169 customer reported a false positive defect.Neither photos nor returned good samples were received.Bd was unable to reproduce customer experience with the bactec product.A false positive response was not observed when retention samples were tested.Batch history records were reviewed, and all testing were within specification for product release.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.Users are cautioned in the package insert under limitation of the procedure: ¿a gram-stained smear from culture medium may contain small number of non-viable organisms derived from media constituents, staining reagents, immersion oil, glass slide and specimens used for inoculation.There are many factors that can influence the false positive rate, including blood volume, blood cell counts, environmental factors, and media lot to lot variations.Complaint is unconfirmed based on retention samples and batch history record review.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.Plot/log file review: there is nothing in the log files that is suggesting any voltage or rack issue was present.The unit is functioning as intended.However, the log files showed the voltage outputs ( the readable ones to the computer, not the actual voltages going to the system) were reading significantly off.This may be contributed to a grounding issue, or some other issue with the edb.

• Brand Name: BD BACTEC¿ STANDARD/10 AEROBIC/F CULTURE VIALS (PLASTIC)
• 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: 14604635
• Report Number: 2647876-2022-00153
• Device Sequence Number: 12053191
• Product Code: MDB
• UDI-Device Identifier: 00382904420277
• UDI-Public: 00382904420277
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K161810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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: 09/30/2022
• Device Model Number: 442027
• Device Catalogue Number: 442027
• Device Lot Number: 1245169
• 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: 05/09/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• 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