MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING

Model Number 442022

Device Problem False Positive Result (1227)

Patient Problem Sepsis (2067)

Event Date 02/17/2023

Event Type  malfunction  

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 1 of 2.It was reported that bd bactec¿ plus anaerobic/f culture vials (plastic) c.Tropicalis molecular false positive being reported.The following information was provided by the initial reporter: gram stain: gpc in pairs and gnrs.1st bcid2 run detected e.Faecium and k.Pneumoniae - reported to pharmacy.Repeat bcid2 detected e.Faecium, k.Pneumoniae, and c.Tropicalis.C.Tropicalis was reported to pharmacy, but informed pharmacy that yeast was not seen in gram stain.Results reported to physician: (b)(6).

Event Description

Report 2 of 2 it was reported that bd bactec¿ plus anaerobic/f culture vials (plastic) c.Tropicalis molecular false positive being reported.The following information was provided by the initial reporter: gram stain: gpc in pairs and clusters bcid 2 - detected stap epidermidis and c.Tropicalis repeat bcid2 had no c.Tropicalis only staph epidermidis reported to doctor.

Manufacturer Narrative

H.6.Investigation summary: customer reported a molecular false positive result.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.Product insert warnings and precautions sections states that prior to use, each vial should be examined for evidence of contamination such as cloudiness, bulging or depresses septum, or leakage.Vials showing evidence of contamination should not be used.Also prior to use, the user should examine the vial for evidence of damage or deterioration.Vials displaying turbidity, contamination, or discoloration (darkening) should not be used.Refer to customer letter.Users are cautioned in the package insert under limitation of the procedure: ¿a gram-stained smear from culture medium may contain small number of non-viable organisms derived from media constituents, staining reagents, immersion oil, glass slide and specimens used for inoculation.There are many factors that can influence the false positive rate, including blood volume, blood cell counts, environmental factors, and media lot to lot variations.

• Brand Name: BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS (PLASTIC)
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17095782
• MDR Text Key: 316856098
• Report Number: 1119779-2023-00627
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420222
• UDI-Public: 00382904420222
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141810
• 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: 07/20/2023

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: 442022
• Device Catalogue Number: 442022
• 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: 06/09/2023
• Supplement Dates Manufacturer Received: 07/20/2023
• Supplement Dates FDA Received: 07/27/2023
• 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: 72 YR
• Patient Sex: Female