MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS; SYSTEM, BLOOD CULTURING

Catalog Number 442288

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/17/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: no event occurrence date provided.Used awareness date from global complaint.Medical device expiration date: unknown.Initial reporter addr 1: (b)(6).Pma/510(k)#: k970512, k970333.Device manufacture date: unknown.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¿ myco/f lytic culture vials there were three occurrences of false positive results due to possible contamination.Confirmatory testing was done via slide observation and the presence of low quantitative of spherical bacterial cocci associated in pairs, also known as diplococci, was observed.In addition, the complementary test tb mpt64 was performed.There was no patient impact.The following information was provided by the initial reporter: medium used to identify mycobacteria, yeasts or fungi.However, the customer notes that the equipment is releasing positive results and when performing confirmatory tests, these types of microorganisms are not found, but the presence of diplococci was observed."the doctor reported that our myco/f lytic medium blood culture bottle is releasing false positive results.When the 9050 equipment (series n.: (b)(4)) releases the positive result, she performs a confirmatory test via slide observation and observes the presence of low quantitative of spherical bacterial cocci associated in pairs also known as diplococci.In addition, performs the complementary test tb mpt64.Complementary manual tests do not identify the presence of mycobacteria, yeasts or fungi, the only evidence is the presence of diplococci.Note: the customer was unable to inform the batch number of the vials.".

Event Description

It was reported that while using bd bactec¿ myco/f lytic culture vials there were three occurrences of false positive results due to possible contamination.Confirmatory testing was done via slide observation and the presence of low quantitative of spherical bacterial cocci associated in pairs, also known as diplococci, was observed.In addition, the complementary test tb mpt64 was performed.There was no patient impact.The following information was provided by the initial reporter: medium used to identify mycobacteria, yeasts or fungi.However, the customer notes that the equipment is releasing positive results and when performing confirmatory tests, these types of microorganisms are not found, but the presence of diplococci was observed."the doctor reported that our myco/f lytic medium blood culture bottle is releasing false positive results.When the 9050 equipment (series n.:(b)(6) releases the positive result, she performs a confirmatory test via slide observation and observes the presence of low quantitative of spherical bacterial cocci associated in pairs also known as diplococci.In addition, performs the complementary test tb mpt64.Complementary manual tests do not identify the presence of mycobacteria, yeasts or fungi, the only evidence is the presence of diplococci.Note: the customer was unable to inform the batch number of the vials.".

Manufacturer Narrative

H.6 investigation summary: catalog 442288.Batch no.Unknown.Customer reported a contamination defect.Neither photos nor returned good samples were received.Bd was not able to perform an investigation to the retention samples since batch 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.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.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.Complaint is unconfirmed.No correctives 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 investigation process.H3 other text : see h.10.

• Brand Name: BD BACTEC¿ MYCO/F LYTIC CULTURE VIALS
• 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: 15392451
• MDR Text Key: 305739476
• Report Number: 2647876-2022-00192
• Device Sequence Number: 1
• Product Code: MDB
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: SEE H.10
• 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: 09/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 442288
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2022
• 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