MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ PLUS AEROBIC/F CULTURE VIAL; SYSTEM, BLOOD CULTURING

Model Number	442192
Medical Device Problem Codes	Leak/Splash (1354); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
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 that while using bd bactec¿ plus aerobic/f culture vial, leaking of a patient sample and false positive result were obtained by the laboratory personnel.There was no indication that results were reported, and there was no patient impact.The following information was provided by the initial reporter: bactec bottle leaking.Positive bottle.Customer was able to safely obtain a gramstain and subculture from the bottle and confirmed that the bottle was positive.
Additional Manufacturer Narrative
H.6.Investigation: customer reported a false positive result and a leakage defect.Bd was unable to reproduce customer experience with the bactec product.A false positive response was not observed when retention samples were tested.Satisfactory results were obtained from retention samples when visually inspected for any cap defect or leakage.Vacuum draw was performed with satisfactory results.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.Complaint is unconfirmed based on retention samples and batch history review results.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.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.On rare occasions, a vial may not be sealed sufficiently the contents of the vials may leak or spill, especially if the vial is inverted.If the vial has been inoculated, treat the leak or spill with caution, as pathogenic organism/agents may be present.To minimize the potential or leakage during inoculation of specimen into culture vials, use syringes with permanently attached needles or bd luer-lok tips.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.
Event or Problem Description
It was reported that while using bd bactec¿ plus aerobic/f culture vial, leaking of a patient sample and false positive result were obtained by the laboratory personnel.There was no indication that results were reported, and there was no patient impact.The following information was provided by the initial reporter: bactec bottle leaking.Positive bottle.Customer was able to safely obtain a gramstain and subculture from the bottle and confirmed that the bottle was positive.

• Brand Name: BD BACTEC¿ PLUS AEROBIC/F CULTURE VIAL
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12712643
• Report Number: 2647876-2021-00228
• Device Sequence Number: 4489419
• Product Code: MDB
• UDI-Device Identifier: 00382904421922
• UDI-Public: 00382904421922
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K083572
• 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): 12/10/2021

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: 03/31/2022
• Device Model Number: 442192
• Device Catalogue Number: 442192
• Device Lot Number: 1160534
• 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: 09/30/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2021
• 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