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 Negative Result (1225)

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

Event Date 10/06/2022

Event Type  malfunction  

Event Description

It was reported that bd bactec¿ plus aerobic/f culture vials (plastic) had a false negative blood culture after a 5 day incubation.A week later another blood culture was sent for analysis and gave a positive result.The negative bottle was still available and sub cultured, which gave a positive result.Both negative and positive blood culture bottles contained francisella tularensis.No patient impact was reported.The following information was provided by the initial reporter: false negative blood culture.Blood culture was performed and gave a negative result after 5 day incubation.One week later, another blood culture was sent for analysis and gave a positive result.The negative bottle was still available and subcultured.This subculture from the negative bottle was positive.I need to specify: the negative and positive blood culture bottles contained francisella tularensis.The lot number is unfortunately not available anymore.The bottles have been discarded.However, i can provide the barcode number of the bottle, as this was available in epicentre: 449283366231 the serial number of the instrument is (b)(4).

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

D.4.Lot # and expiration date have been updated from unknown to --- lot number: 1153264, expiration date: 03/31/2022.

Event Description

It was reported that bd bactec¿ plus aerobic/f culture vials (plastic) had a false negative blood culture after a 5 day incubation.A week later another blood culture was sent for analysis and gave a positive result.The negative bottle was still available and sub cultured, which gave a positive result.Both negative and positive blood culture bottles contained francisella tularensis.No patient impact was reported.The following information was provided by the initial reporter: false negative blood culture.Blood culture was performed and gave a negative result after 5 day incubation.One week later, another blood culture was sent for analysis and gave a positive result.The negative bottle was still available and subcultured.This subculture from the negative bottle was positive.I need to specify: the negative and positive blood culture bottles contained francisella tularensis.The lot number is unfortunately not available anymore.The bottles have been discarded.However, i can provide the barcode number of the bottle, as this was available in epicentre: 449283366231 the serial number of the instrument is (b)(6).

Event Description

It was reported that bd bactec¿ plus aerobic/f culture vials (plastic) had a false negative blood culture after a 5 day incubation.A week later another blood culture was sent for analysis and gave a positive result.The negative bottle was still available and sub cultured, which gave a positive result.Both negative and positive blood culture bottles contained francisella tularensis.No patient impact was reported.The following information was provided by the initial reporter: false negative blood culture.Blood culture was performed and gave a negative result after 5 day incubation.One week later, another blood culture was sent for analysis and gave a positive result.The negative bottle was still available and subcultured.This subculture from the negative bottle was positive.I need to specify: the negative and positive blood culture bottles contained francisella tularensis.The lot number is unfortunately not available anymore.The bottles have been discarded.However, i can provide the barcode number of the bottle, as this was available in epicentre: (b)(6).The serial number of the instrument is (b)(6).

Manufacturer Narrative

Investigation summary: customer reported a false negative result.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 was not reviewed as the lot is expired, 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.The specimen must be collected using sterile techniques to reduce the chance of contamination.Do not use culture vials past their expiration date.Complaint is unconfirmed.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.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15652058
• MDR Text Key: 306932373
• Report Number: 2647876-2022-00223
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: 00382904420239
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K113558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2022

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 Expiration Date: 03/31/2022
• Device Model Number: 442023
• Device Catalogue Number: 442023
• Device Lot Number: 1153264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 11/08/2022; 11/16/2022
• Supplement Dates FDA Received: 11/17/2022; 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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