MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) 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 09/01/2022

Event Type  malfunction  

Event Description

It was reported that while using bd bactec¿ plus aerobic/f culture vials (plastic) there was one false negative blood culture.The aerobic bottle was detected as negative in the bactec fx, but the gram preparation and the subculture were positive with e.Coli and enterococcus faecalis.Results were not reported to the clinician and there was no patient impact.The following information was provided by the initial reporter: 02-sep-2022 - additional info: material: punctate of an abscess of the lumbar spine the false negative result has not been submitted to the hospital, so no impact for the patient.False negative blood culture.Renewed complaint about a false negative blood culture bottle.The aerobic bottle is detected as negative in the bactec fx, the gram preparation and the subculture are positive with e.Coli and enterococcus faecalis.The anaerobic bottle is positive in the device, also with e.Coli and enterococcus faecalis.The sample material in both bottles was a punctate.Growth curves and the vial picture are attached.Log files will be submitted later by the customer.Is a negative bottle from the instrument always gram stained and subcultured?---> no if not, why did they do it in this case? the patient sample is an abscess puncture of the lumbar spine.One aerobic and one anaerobic bactec vial was inoculated.Patient sample was not clear/turbid so it was gram stained and subcultures were made.Gram stain: gram positive cocci and gram negative rods.Subculture: e.Faecalis (pos.Cocci) , no growth of gram negative rods so far.

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¿ plus aerobic/f culture vials (plastic) there was one false negative blood culture.The aerobic bottle was detected as negative in the bactec fx, but the gram preparation and the subculture were positive with e.Coli and enterococcus faecalis.Results were not reported to the clinician and there was no patient impact.The following information was provided by the initial reporter: 02-sep-2022 - additional info: material: punctate of an abscess of the lumbar spine the false negative result has not been submitted to the hospital, so no impact for the patient.False negative blood culture.Renewed complaint about a false negative blood culture bottle.The aerobic bottle is detected as negative in the bactec fx, the gram preparation and the subculture are positive with e.Coli and enterococcus faecalis.The anaerobic bottle is positive in the device, also with e.Coli and enterococcus faecalis.The sample material in both bottles was a punctate.Growth curves and the vial picture are attached.Log files will be submitted later by the customer.Is a negative bottle from the instrument always gram stained and subcultured?---> no.If not, why did they do it in this case? ---> the patient sample is an abscess puncture of the lumbar spine.One aerobic and one anaerobic bactec vial was inoculated.Patient sample was not clear/turbid so it was gram stained and subcultures were made.Gram stain: gram positive cocci and gram negative rods.Subculture: e.Faecalis (pos.Cocci) , no growth of gram negative rods so far.

Manufacturer Narrative

H.6 investigation summary: one photo of a bottle was 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.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 & 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: 15459987
• MDR Text Key: 306164937
• Report Number: 1119779-2022-01211
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: 00382904420239
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Model Number: 442023
• Device Catalogue Number: 442023
• Device Lot Number: 1252602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• 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