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

Model Number 442021

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem Bacterial Infection (1735)

Event Date 05/03/2022

Event Type  Injury  

Event Description

It was reported that customer had several instances of identified organisms they suspect to be contamination from bd bactec¿ lytic/10 anaerobic/f culture vials (plastic)- lot #2040802.Three patients affected by decision to administer antibiotics.

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 customer had several instances of identified organisms they suspect to be contamination from bd bactec¿ lytic/10 anaerobic/f culture vials (plastic)- lot #2040802.Three patients affected by decision to administer antibiotics.

Manufacturer Narrative

H6: investigation summary : catalog 442021; batch no.2040802.Customer reported a contamination issue while using bactec product.Returned good samples were received.Bd was unable to reproduce the customer¿s experience with bactec product.Retention/returned 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/returned samples and batch history record review.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.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 & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14889733
• MDR Text Key: 295151843
• Report Number: 2647876-2022-00167
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Model Number: 442021
• Device Catalogue Number: 442021
• Device Lot Number: 2040802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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
• Patient Outcome(s): Required Intervention