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

Model Number 442023

Device Problem False Positive Result (1227)

Patient Problem Pleural Effusion (2010)

Event Date 02/03/2023

Event Type  malfunction  

Event Description

Report 2 of 7 it was reported while using bd bactec¿ plus aerobic/f culture vials (plastic) bcid detected staph species and candida tropicalis.The following information was provided by the initial reporter: gram stain revealed gram positive cocci in pairs and clusters from aerobic bottle.Bcid detected staph species and candida tropicalis.Repeat filmarray- bcid- no candida tropicalis detected.Staph species grew in culture.Confirmatory testing was culture.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

Report 2 of 7: it was reported while using bd bactec¿ plus aerobic/f culture vials (plastic) bcid detected staph species and candida tropicalis.The following information was provided by the initial reporter: gram stain revealed gram positive cocci in pairs and clusters from aerobic bottle.Bcid detected staph species and candida tropicalis.Repeat filmarray- bcid- no candida tropicalis detected.Staph species grew in culture.Confirmatory testing was culture.

Manufacturer Narrative

H.6 investigation summary: catalog: 442023.Batch no.:3031790 & 3011327.Customer reported a positive id result for bactec media, while using biofire filmarray® blood culture identification.Neither photos nor returned good samples were received.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.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 record review results.Catalog 442023.Batch no.Unknown.Customer reported a positive id result for bactec media, while using biofire filmarray® blood culture identification.Neither photos nor returned good samples were received.Bd was not able to perform an investigation to the retention samples since batch 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.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.

• Brand Name: BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
• Type of Device: 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17102346
• MDR Text Key: 317161449
• Report Number: 3008352382-2023-00106
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: 00382904420239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2023
• Initial Date FDA Received: 06/11/2023
• Supplement Dates Manufacturer Received: 07/18/2023
• Supplement Dates FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Female