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 Negative Result (1225)

Patient Problem Sepsis (2067)

Event Date 05/13/2021

Event Type  Injury  

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 anaerobic/f culture vials (plastic) a false negative result was obtained by the laboratory personnel.A gram stain test was used to confirm the results as a false negative.The patient was treated for sepsis.The following information was provided by the initial reporter: " bactec anaerobic bottle was loaded on 8th may, and flagged positive 4 days later on 12th may.Initial review of the direct blood gram stain showed no organism.Direct plating was also performed.The bottle was then re-loaded back into its position on the bactec instrument.The bottle on the bactec did not subsequently flag positive after it was returned, and was ejected as 'negative' on 13th may after the routine 5-day incubation period.Growth was observed on the anaerobic schaedler agar on 14th may, and colony was identified as fusobacterium nucleatum using the vitek ms maldi.Colony gram stain showed long sphindle-shaped gram negative bacilli (gnb); its morphology also matched the identification.Patient had to be treated for sepsis.

Event Description

It was reported that while using bd bactec¿ plus anaerobic/f culture vials (plastic) a false negative result was obtained by the laboratory personnel.A gram stain test was used to confirm the results as a false negative.The patient was treated for sepsis.The following information was provided by the initial reporter: "bactec anaerobic bottle was loaded on (b)(6), and flagged positive 4 days later on (b)(6).Initial review of the direct blood gram stain showed no organism.Direct plating was also performed.The bottle was then re-loaded back into its position on the bactec instrument.The bottle on the bactec did not subsequently flag positive after it was returned, and was ejected as 'negative' on (b)(6) after the routine 5-day incubation period.Growth was observed on the anaerobic schaedler agar on (b)(6), and colony was identified as fusobacterium nucleatum using the vitek (b)(6).Colony gram stain showed long sphindle-shaped gram negative bacilli (gnb); its morphology also matched the identification.Patient had to be treated for sepsis.".

Manufacturer Narrative

Fracture zest dental locator abutment was received for investigation.Zest quality assurance has conducted an investigation for the suspected device.The complaint report was received, reviewed, and evaluated by the zest dental solutions complaint process in compliance with applicable fda and ous country regulations.Applicable zest internal lot history records were reviewed to evaluate whether any internal deviations, non-conformances, or problems occurred during the manufacture of the lot, which could cause or contribute to the reported complaint condition.A review of other zest complaint files and related trending data for similar incidents was performed to evaluate whether other similar complaints have been received and if data suggests any adverse trends may have contributed to the complaint root cause.No manufacturing defect/event was noted, event is tracked and trended with no further actions taken at this time.Therefore, based on the evaluation, the malfunction had occurred, thread fracture was identified during function and this report was confirmed following inspection.Fracture during function typically results from insufficient tightening torque at placement, overloading of the abutment in function, or not retightening the abutment at prescribed intervals.

• 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
• MDR Report Key: 12002066
• MDR Text Key: 256804161
• Report Number: 3008352382-2021-00159
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420222
• UDI-Public: 00382904420222
• Combination Product (y/n): N
• PMA/PMN Number: K141810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2021
• Device Model Number: 442022
• Device Catalogue Number: 442022
• Device Lot Number: 1025343
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/16/2021
• Initial Date FDA Received: 06/15/2021
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention