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

Model Number	442027
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd bactec¿ standard/10 aerobic/f culture vials (plastic) produced a false positive acinetobacter result when no gnr seen in the gram stain.There was no indication of confirmatory testing, or that results were reported.There was also no report of patient impact.The following information was provided by the initial reporter: "customer problem: positive blood culture bottle that biofire identified as an acinetobacter where there was no gnr seen in the gram stain.".
Event or Problem Description
It was reported that the bd bactec¿ standard/10 aerobic/f culture vials (plastic) produced a false positive acinetobacter result when no gnr seen in the gram stain.There was no indication of confirmatory testing, or that results were reported.There was also no report of patient impact.The following information was provided by the initial reporter: "customer problem: positive blood culture bottle that biofire identified as an acinetobacter where there was no gnr seen in the gram stain.".
Additional Manufacturer Narrative
H.6.Investigation: customer reported a positive id result for bactec media, while using biofire filmarray® blood culture identification bdic/bcid2 panels.Investigation cannot be conducted to the retention samples since the lot 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 catalog reported 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.Complaint is unconfirmed.As per product insert a gram-stained smear from culture medium may contain small numbers of nonviable organisms derived from media constituents, staining reagents, immersion oil, glass slides, and specimens used for inoculation.Due to the nature of biological materials in media products and inherent organism variability, the user should be cognizant of potential variable results in the recovery of certain microorganisms.Molecular tests performed on positive blood cultures will detect both viable and non-viable organisms commonly found in culture media.Therefore, molecular test results should be evaluated in conjunction with gram stain results in accordance with standard-of-care practices as well as manufacturer¿s instructions for use.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.

• Brand Name: BD BACTEC¿ STANDARD/10 AEROBIC/F CULTURE VIALS (PLASTIC)
• Common Device Name: BLOOD CULTURING SYSTEM
• 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: 12537450
• Report Number: 2647876-2021-00131
• Device Sequence Number: 1348699
• Product Code: MDB
• UDI-Device Identifier: 00382904420277
• UDI-Public: 00382904420277
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,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 Model Number: 442027
• Device Catalogue Number: 442027
• Device Lot Number: UNKNOWN
• 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: 08/31/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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