MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING

Model Number 442021

Device Problem False Positive Result (1227)

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

Event Date 10/05/2021

Event Type  malfunction  

Event Description

It was reported that the bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) produced a molecular false positive.Gram strains were done with no negative growth present.There was no indication that results were reported to clinicians, and there was no adverse patient impact.This complaint was created to capture the 2nd of 4 related incidents.The following information was provided by the initial reporter: "customer reporting gram negative id with bcid eplex gp when testing 442021 bottles, but no growth is seen in culture." "patient #2 bottle lot number: 1167457.Please provide the date this patient was tested on the bcid eplex gp: (b)(6) 2021.Was eplex result dual positive? yes.Bcid eplex-gp- staphylococcus, staphylococcus epidermidis, meca and pan-gn.Bcid eplex-gn- pan gp.Time to positivity? ~18 hours.Was any organism seen on the gram stain for this bottle? gram positive cocci.Was the bottle plated to media? if so what type? blood, chocolate.Did any organism grow in culture? staphylococcus epidermidis.No gram negative growth.".

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) produced a molecular false positive.Gram strains were done with no negative growth present.There was no indication that results were reported to clinicians, and there was no adverse patient impact.This complaint was created to capture the 2nd of 4 related incidents.The following information was provided by the initial reporter: "customer reporting gram negative id with bcid eplex gp when testing 442021 bottles, but no growth is seen in culture." "patient #2 *bottle lot number: 1167457 *please provide the date this patient was tested on the bcid eplex gp: (b)(6) 2021.*was eplex result dual positive? yes.-bcid eplex-gp- staphylococcus, staphylococcus epidermidis, meca and pan-gn.-bcid eplex-gn- pan gp.*time to positivity? ~18 hours.*was any organism seen on the gram stain for this bottle? gram positive cocci.*was the bottle plated to media? if so what type? blood, chocolate.*did any organism grow in culture? staphylococcus epidermidis.No gram negative growth".

Manufacturer Narrative

H.6.Investigation: customer reported a positive id result for bactec media, while using genmark bcid eplex.Bd was unable to reproduce the customer¿s experience with the bactec product based on our internal procedures and the intended use of the product.Retention samples were visually inspected, tested for viable contamination by sub-culturing on tsa, chocolate, sabouraud and schaedler agars plates, voltage output and gram stain.All results were satisfactory.Batch history record review did not identify any evidence for which the customer submitted the complaint.Batch has been previously investigated for the reported defect.No additional testing is required at this time.Complaint is unconfirmed based on retention samples and batch history record review results.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.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¿ LYTIC/10 ANAEROBIC/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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12933723
• MDR Text Key: 288897477
• Report Number: 2647876-2021-00338
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420215
• UDI-Public: 00382904420215
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123903
• 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: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• 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: 442021
• Device Catalogue Number: 442021
• Device Lot Number: 1167457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2021
• 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