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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2022

Event Type  malfunction  

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 Description

It was reported that bd bactec¿ plus anaerobic/f culture vials (plastic) 15 false positives have been occurring.The following information was provided by the initial reporter: customer states more than 15 fp; no injuries occurred.

Event Description

It was reported that bd bactec¿ plus anaerobic/f culture vials (plastic) 15 false positives have been occurring.The following information was provided by the initial reporter: customer states more than 15 fp no injuries occurred.

Manufacturer Narrative

H6 investigation summary: catalog 442022 batch no.2013115 customer reported a false positive result.Neither photos nor returned good samples were received.The plus anaerobic/f epi plot showed low voltages prior to the positive detection.Very low voltages will cause false positives with anaerobic media.Product support recommends an fse evaluate the racks and/or leds.Upon further evaluation it was noticed that complaint received was from a product already expired.Investigation cannot be conducted to the retention samples since the product is already expired.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.The batch history record was not reviewed as the lot is expired, nonetheless batch history records are always reviewed prior to product release.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.Complaint is unconfirmed.No correctives actions were required.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16043489
• MDR Text Key: 306837575
• Report Number: 1119779-2022-01542
• Device Sequence Number: 1
• Product Code: MDB
• 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: 02/18/2023

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: 442022
• Device Catalogue Number: 442022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 02/18/2023
• Supplement Dates FDA Received: 03/06/2023
• 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