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 Positive Result (1227)

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

Event Date 09/03/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that while testing with bd bactec¿ plus aerobic/f culture vials (plastic) a false gram negative result was obtained.Confirmatory culture showed no gram-negative growth.There was no reported patient impact.The following information was provided by the initial reporter: customer reporting bcid eplex- gp testing on 442023 bottles resulted gram negative but no gram negative grew in culture.Patient #1.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 staphylococcus, staphylococcus epidermidis and pan-gn, pan candida, meca.Bcid eplex fp ¿ candida glabrata(no false results).Bcid eplex gn- pan gp, pan candida(no false results).Time to positivity? 54 hours.Was any organism seen on the gram stain for this bottle? if so what was the organism reported? gram positive cocci in clusters.No gram negative or yeast seen on stain.Was the bottle plated to media? if so what type? used wasp lab.No further information given.Did any organism grow in culture? coag negative staph and candida glabrata.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

Investigation summary: customer reported a positive id result for bactec media, while using genmark bcid eplex.Investigation cannot be conducted to the retention samples since the lot number is unknown.A complaint history review cannot be conducted relating to the incident lot number and the ¿as reported¿ defect code since batch number is unknown.Complaints for catalog reported have been received.The batch history record could not be reviewed as the lot number is unknown nonetheless batch history records are always reviewed prior to product release.Complaint is unconfirmed.Customer complaints for molecular false positive have been received but 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.Refer to customer letter attached.No corrective nor further 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 h10.

Event Description

It was reported that while testing with bd bactec¿ plus aerobic/f culture vials (plastic) a false gram negative result was obtained.Confirmatory culture showed no gram-negative growth.There was no reported patient impact.The following information was provided by the initial reporter: customer reporting bcid eplex- gp testing on 442023 bottles resulted gram negative but no gram negative grew in culture.Patient #1 *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 staphylococcus, staphylococcus epidermidis and pan-gn, pan candida, meca -bcid eplex fp ¿ candida glabrata(no false results).-bcid eplex gn- pan gp, pan candida(no false results).*time to positivity? 54 hours *was any organism seen on the gram stain for this bottle? if so what was the organism reported? gram positive cocci in clusters.No gram negative or yeast seen on stain.*was the bottle plated to media? if so what type? used wasp lab.No further information given.*did any organism grow in culture? coag negative staph and candida glabrata.*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.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12928882
• MDR Text Key: 290276722
• Report Number: 2647876-2021-00320
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: 00382904420239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113558
• 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: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 442023
• Device Catalogue Number: 442023
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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