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

Model Number 442022

Device Problem False Positive Result (1227)

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

Event Date 09/24/2021

Event Type  malfunction  

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 while using bd bactec¿ plus anaerobic/f culture vials (plastic) on bcid eplex gp gram negative results were obtained.Confirmatory gram testing had no gram negative growth.There was no report of results being reported and there was no patient impact.The following information was provided by the initial reporter: customer reporting gram negative result with bcid eplex gp when testing 442022 bottles, but no gram negative grows in culture.Patient #7 bottle lot number: 1174515 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- resulted as (b)(6), meca and pan-gn.Bcid eplex gn ¿ pan-gp only.Time to positivity? 12 hours 45 minutes.Was any organism seen on the gram stain for this bottle? gram positive cocci in clusters.No gram negative seen.Was the bottle plated to media? if so what type? blood, chocolate, mac.Did any organism grow in culture? coag neg staph(meca detected).No gram-negative growth.You state for this patient the organism was not reported out, correct? customer did not provide.They just provided that no adverse events were reported.Can you provide the serial number of the bactec the bottle was in when it went positive? the rack? the drawer? customer unable to provide.

Event Description

It was reported that while using bd bactec¿ plus anaerobic/f culture vials (plastic) on bcid eplex gp gram negative results were obtained.Confirmatory gram testing had no gram negative growth.There was no report of results being reported and there was no patient impact.The following information was provided by the initial reporter: customer reporting gram negative result with bcid eplex gp when testing 442022 bottles, but no gram negative grows in culture.Patient #7 *bottle lot number: 1174515 *please provide the date this patient was tested on the bcid eplex gp: sep/24/2021 *was eplex result dual positive? yes.-bcid eplex-gp- resulted as staphylococcus, staphylococcus epidermidis, meca and pan-gn -bcid eplex gn ¿ pan-gp only *time to positivity? 12 hours 45 minutes *was any organism seen on the gram stain for this bottle? gram positive cocci in clusters.No gram negative seen.*was the bottle plated to media? if so what type? blood, chocolate, mac *did any organism grow in culture? coag neg staph(meca detected).No gram-negative growth *you state for this patient the organism was not reported out, correct? customer did not provide.They just provided that no adverse events were reported.*can you provide the serial number of the bactec the bottle was in when it went positive? the rack? the drawer? customer unable to provide.

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.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.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.H3 other text : see h.10.

• Brand Name: BD BACTEC¿ PLUS 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12936972
• MDR Text Key: 285074406
• Report Number: 2647876-2021-00345
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420222
• UDI-Public: 00382904420222
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141810
• 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: 12/13/2021

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: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 442022
• Device Catalogue Number: 442022
• Device Lot Number: 1174515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 12/13/2021
• Supplement Dates FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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