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

Model Number 442021

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

Patient Problem Sepsis (2067)

Event Date 03/09/2021

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.

Event Description

It was reported that while using bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) a false negative candida sepsis result was obtained by the laboratory personnel.There was no suspicion of fungi indicated by the clinic.The patient died on (b)(6) with sepsis.

Event Description

It was reported that anaerobic 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 patients anaerobic vials was sub-cultured 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.

Manufacturer Narrative

The following fields have been updated with corrections: b.5.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.".H.6 investigation summary: catalog 442021, batch no.0267321.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: lytic plot filed (b)(6) 2021 appeared to be a typical negative plot.Lytic plots filed (b)(6) 2021 are atypical plots which show a late (2-3 days in protocol) gradual increase in fluorescence and could be due to the sporadic, low-level growth that candida species sometimes exhibit in anaerobic media but may be insufficient to flag positive.H3 other text : see h.10.

• Brand Name: BD BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC)
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• MDR Report Key: 11478096
• MDR Text Key: 239624672
• Report Number: 3008352382-2021-00069
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420215
• UDI-Public: 00382904420215
• Combination Product (y/n): N
• PMA/PMN Number: K123903
• 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: 03/23/2021

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: 07/31/2021
• Device Model Number: 442021
• Device Catalogue Number: 442021
• Device Lot Number: 0267321
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2021
• Initial Date FDA Received: 03/12/2021
• Supplement Dates Manufacturer Received: 03/23/2021
• Supplement Dates FDA Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death