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

Model Number 442020

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/07/2022

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 while using bd bactec¿ peds plus¿/ f culture vials (plastic) the customer was complaining for false positive vials, lot no.1294782, this bottle also false positive for proteus on bcid bio fire test.The following information was reported "the customer indicates, no gram stain prior to make molecular test, no observable defect on the bottles, or extreme ambient conditions prior to use.These vials were purchased directly to bd, quantity pending to confirmation.Was the discrepant result reported and was there any treatment change as a result? yes.Customer is looking for having this documented, since there was a discrepant result reported.Bcid panel v2.0 serial no.(b)(4), lot no 2be722 bd bactec bottle was not gram stained prior to the molecular assay, and after subculture was negative to growth.Information attached on mails and biofire result sheet.Based on this attachment and since it was not a dual positive, and only proteus was detected, the instrument false positive on the related case (b)(4) gets relevance.Biofire information: bcid panel v2.0 serial no.(b)(4), lot no 2be722 bd bactec bottle was not gram stained prior to the molecular assay, and after subculture was negative to growth.Information attached on mails and biofire result sheet.Based on this attachment and since it was not a dual positive, and only proteus was detected, the instrument false positive on the related case (b)(4) gets relevance.".

Manufacturer Narrative

H.6 investigation summary: catalog: 442020; batch no.: 1294782.Customer reported a positive id result for bactec media, while using biofire filmarray® blood culture identification bdic/bcid2 panels.Neither photos nor returned good samples were received.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 could not be reviewed as the lot is expired, nonetheless batch history records are always reviewed prior to product release.As per product insert a gram-stained smear from culture medium may contain small numbers of nonviable organisms derived from media constituents, staining reagents, immersion oil, glass slides, and specimens used for inoculation.Due to the nature of biological materials in media products and inherent organism variability, the user should be cognizant of potential variable results in the recovery of certain microorganisms.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 manufacturer¿s instructions for use.Complaint is unconfirmed.Refer to customer letter (b)(4).No corrective 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 investigational process.

Event Description

It was reported that while using bd bactec¿ peds plus¿/ f culture vials (plastic) the customer was complaining for false positive vials, lot no.1294782, this bottle also false positive for proteus on bcid bio fire test.The following information was reported "the customer indicates, no gram stain prior to make molecular test, no observable defect on the bottles, or extreme ambient conditions prior to use.These vials were purchased directly to bd, quantity pending to confirmation.Was the discrepant result reported and was there any treatment change as a result? yes.Customer is looking for having this documented, since there was a discrepant result reported.Bcid panel v2.0 serial no.(b)(6), lot no 2be722.Bd bactec bottle was not gram stained prior to the molecular assay, and after subculture was negative to growth.Information attached on mails and biofire result sheet.Based on this attachment and since it was not a dual positive, and only proteus was detected, the instrument false positive on the related case (b)(4) gets relevance.Biofire information: bcid panel v2.0 serial no.(b)(6), lot no 2be722.Bd bactec bottle was not gram stained prior to the molecular assay, and after subculture was negative to growth.Information attached on mails and biofire result sheet.Based on this attachment and since it was not a dual positive, and only proteus was detected, the instrument false positive on the related case (b)(4) gets relevance.".

• Brand Name: BD BACTEC¿ PEDS PLUS¿/ 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: 15222012
• MDR Text Key: 305345289
• Report Number: 1119779-2022-01100
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420208
• UDI-Public: 00382904420208
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151866
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Model Number: 442020
• Device Catalogue Number: 442020
• Device Lot Number: 1294782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1