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

Model Number	442194
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	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 peds plus/ f culture vials false positive results were obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.
Event or Problem Description
It was reported that while using bd bactec¿ peds plus¿/ f culture vials false positive results were obtained by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.
Additional Manufacturer Narrative
H.6.Investigation: customer reported a positive pseudomonas aeruginosa id result for bactec media, while using biofire filmarray® blood culture identification bdic/bcid2 panels.Bd was unable to reproduce the customer¿s experience with the bactec product based on our internal procedures and the intended use of the product.Retention samples were visually inspected, tested for viable contamination by sub-culturing on tsa, chocolate, sabouraud and schaedler agars plates, voltage output and gram stain.All results were satisfactory.Batch history record review did not identify any evidence for which the customer submitted the complaint.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.Although bd is unable to confirm the complaint, we have initiated capa # 2631844 to further investigate these reports and determine any appropriate actions to reduce their occurrence.

• Brand Name: BD BACTEC PEDS PLUS/ 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: 11490582
• Report Number: 3008352382-2021-00072
• Device Sequence Number: 4602304
• Product Code: MDB
• UDI-Device Identifier: 00382904421946
• UDI-Public: 00382904421946
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K954927
• 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): 04/19/2021

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: 02/28/2021
• Device Model Number: 442194
• Device Catalogue Number: 442194
• Device Lot Number: 0133713
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1