MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC; LYTIC/10 ANAEROBIC/F CULTURE VIALS; SYSTEM, BLOOD CULTURING

Model Number	442265
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9121604.Medical device expiration date: 2020-02-29.Device manufacture date: 2019-05-01.Medical device lot #: 9177949.Medical device expiration date: 2020-04-30.Device manufacture date: 2019-06-26.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that during biofire testing with bd bactec¿; lytic/10 anaerobic/f culture vials false positive results were obtained for pseudomonas.2 results were reported out and 2 patients were treated based of results.Multiple attempts have been made to obtain additional information, the customer has not responded.
Event or Problem Description
It was reported that during biofire testing with bd bactec¿; lytic/10 anaerobic/f culture vials false positive results were obtained for pseudomonas.2 results were reported out and 2 patients were treated based of results.Multiple attempts have been made to obtain additional information, the customer has not responded.
Additional Manufacturer Narrative
H6: investigation summary: catalog: 442021; batch no.: 9121604 & 9177949 expired.Customer reported a positive pseudomonas aeruginosa id result for bactec media, while using biofire filmarray® blood culture identification bdic/bcid2 panels.Upon further evaluation it was noticed that complaint received was from a product already expired.No investigation will be conducted.Batch history records are always reviewed prior product release.Bd bactec system is designed and cleared for the qualitative culture and recovery of anaerobic/aerobic organisms from blood.Bd has no specification for use with molecular testing such as the biofire filmarray® blood culture identification bdic/bcid2 panels.While bd highlights the inherent risk of nonviable organisms in blood culture media in our package insert is stated the 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 manufactures¿ instructions for use.Bd have initiated capa # 2631844 to further investigate these reports and determine any appropriate actions to reduce their occurrence.H3 other text : see h10.

• Brand Name: BD BACTEC; LYTIC/10 ANAEROBIC/F CULTURE VIALS
• Common Device Name: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• MDR Report Key: 11363251
• Report Number: 3008352382-2021-00050
• Device Sequence Number: 11624030
• Product Code: MDB
• UDI-Device Identifier: 00382904422653
• UDI-Public: 00382904422653
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K954925
• 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): 04/13/2021

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: 442265
• Device Catalogue Number: 442021
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 04/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1