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

Model Number 442023

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2021

Event Type  malfunction  

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 #: 0093305, medical device expiration date: 2021-01-31, device manufacture date: 2020-04-02, medical device lot #: 0283856, medical device expiration date: 2021-07-31, device manufacture date: 2020-10-09, medical device lot #: 0301016, medical device expiration date: 2021-08-31, device manufacture date: 2020-10-27.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported while performing biofire testing with bd bactec¿; plus aerobic/f culture vials false positive results were obtained for pseudomonas.Two results were reported and two patients were treated.Multiple attempts have been made to obtain additional information, the customer has not responded.

Manufacturer Narrative

H6: investigation summary: catalog: 442023, batch no.: 0283856 & 0301016.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.

Event Description

It was reported while performing biofire testing with bd bactec¿; plus aerobic/f culture vials false positive results were obtained for pseudomonas.Two results were reported and two patients were treated.Multiple attempts have been made to obtain additional information, the customer has not responded.

• Brand Name: BD BACTEC; PLUS AEROBIC/F CULTURE VIALS
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• MDR Report Key: 11363250
• MDR Text Key: 256809432
• Report Number: 3008352382-2021-00049
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: 00382904420239
• Combination Product (y/n): N
• PMA/PMN Number: K113558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Model Number: 442023
• Device Catalogue Number: 442023
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/22/2021
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1