MAUDE Adverse Event Report: BD CARIBE LTD. BD BACTEC PLUS AEROBIC/F CULTURE VIALS (PLASTIC); BLOOD CULTURE

Model Number 442023

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Fungus (1872)

Event Date 08/21/2020

Event Type  Death  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).Date of death: unknown.The date received by manufacturer has been used for this field.

Event Description

It was reported that a patient died after being tested using the bd bactec¿ plus aerobic/f culture vials (plastic).It was found that the patient was positive for cryptococcus neoformans in a recent blood culture.A sample was taken before death and was negative for the cryptococcal antigen.It is unclear if the death was related to cryptococcus neoformans and it is unclear if the original result was erroneous.

Event Description

It was reported that a patient died after being tested using the bd bactec¿ plus aerobic / f culture vials (plastic).It was found that the patient was positive for cryptococcus neoformans in a recent blood culture.A sample was taken before death and was negative for the cryptococcal antigen.It is unclear if the death was related to cryptococcus neoformans and it is unclear if the original result was erroneous.

Manufacturer Narrative

The following fields were updated due to corrected information: d3: manufacturing location: bd caribe ltd.G2: manufacturing location: bd caribe ltd.H6: investigation summary: bd was unable to reproduce customer¿s experience with bactec product.Satisfactory results were obtained from retention samples when tested for microbial instrument detection as per quality procedures.Even though cryptococcus neoformans is not listed as a limitation in the product insert nor tested as part of the released criteria, bactec plus aerobic media can grow and recover the aforementioned organism.Therefore, this organism was test with positive results.Also, viable contamination, blood background, stainable and voltage output testing were performed, as per quality control procedures, with satisfactory results.Batch history record review did not identify any evidence for which the customer submitted the complaint.Complaint is unconfirmed based on retention samples and batch record review results.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.The specimen must be collected using sterile techniques to reduce the chance of contamination.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 PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
• Type of Device: BLOOD CULTURE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos MD 21152
• MDR Report Key: 10528775
• MDR Text Key: 206820324
• Report Number: 1119779-2020-00323
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: 00382904420239
• Combination Product (y/n): N
• PMA/PMN Number: K113558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2021
• Device Model Number: 442023
• Device Catalogue Number: 442023
• Device Lot Number: 0112467
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 11/09/2020
• Supplement Dates FDA Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death