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

Model Number 442023

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

Patient Problem Sepsis (2067)

Event Date 02/23/2021

Event Type  Death  

Manufacturer Narrative

Mfg report # 3008352382-2021-00069 was the original report of death.This complaint is in reference to the same death event.Investigation summary: catalog 442023, batch no.0261463.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.Batch history record review did not identify any evidence for which the customer submitted the complaint (i.E.False negative).Microbial instrument detection indicated that the product is performing as expected.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.Quality control certificates list test organism, including atcc¿ culture specified in the clsi standard m22, quality control for commercially prepared microbiological culture media.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.Plot review: aerobic plot filled (b)(6) 2021 appeared to be a typical negative plot.Aerobic plots filled (b)(6) 2021 are atypical plots showing linear increase in fluorescence right from the start of protocol, immediately following temperature equilibration.

Event Description

It was reported that aerobic blood culture bottles flagged as false negatives on the bd bactec¿ fx instrument.The patient was a cancer patient that had bi-weekly blood drawn during a routine check-up.The blood was drawn from the patients port on (b)(6) 2021, and the patient expired on (b)(6) 2021 with suspected sepsis.As an internal quality control, the lab subcultures a negative bactec vial every week.One of the 4 blood cultures of this patient was sub-cultured (the anaerobic bottle) and growth of candida was seen.The other vials were discarded and no additional testing could be performed.During the investigation into this incident it was discovered that on (b)(6) 2021, blood cultures were also drawn from this patient.The anaerobic and aerobic vials also resulted as negative on the bactec instrument.The customer is questioning the results from this set of cultures as well.

• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11572776
• MDR Text Key: 242370638
• Report Number: 3008352382-2021-00078
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: 00382904420239
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K113558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2021

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: 06/30/2021
• Device Model Number: 442023
• Device Catalogue Number: 442023
• Device Lot Number: 0261463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2020
• 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): Death