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

Model Number 442023

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem Bacterial Infection (1735)

Event Date 06/09/2022

Event Type  Injury  

Event Description

It was reported that while using bd bactec¿ plus aerobic/f culture vials (plastic) there were three instances of paenibacillus suspected to be contamination.These three results were reported and patients were affected by the decision to administer antibiotics.The following information was provided by the initial reporter: for this case - 4 cases of contamination being reported with 3 patients affected by decision to administer antibiotics, 1 patient was not treated, no further information provided.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: catalog 442023; batch no.2041455.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.H3 other text : see h.10.

Event Description

It was reported that while using bd bactec¿ plus aerobic/f culture vials (plastic) there were three instances of paenibacillus suspected to be contamination.These three results were reported and patients were affected by the decision to administer antibiotics.The following information was provided by the initial reporter: for this case - 4 cases of contamination being reported with 3 patients affected by decision to administer antibiotics, 1 patient was not treated, no further information provided.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14880956
• MDR Text Key: 295124879
• Report Number: 2647876-2022-00165
• 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: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Model Number: 442023
• Device Catalogue Number: 442023
• Device Lot Number: 2041455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 07/06/2022
• Supplement Dates FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2022
• 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