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

Model Number 442022

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 07/04/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

Report 1 of 3.It was reported that during use with the bd bactec¿ plus anaerobic/f culture vials (plastic), a vial was contaminated with lactobacillus paracasei.Erroneous results were reported to the clinician, and the patient was treated based on the erroneous results.The patient expired 21 days later, but there is no indication that the bd product caused or contributed to the patient death.The following information was provided by the initial reporter, translated from french: for the last week, we have observed a strangely high number of blood cultures positive to lactobacillus paracasei (all with the same antibiogram).Additional information received on (b)(6) 2022: cause of death: persistence of a biological inflammatory syndrome, fever with hypotension on (b)(6), unilateral cervical contracture without meningeal stiffness; death observed a few hours after this note.Change in treatment of patient who expired happened on 26/6, then he died on (b)(6).The patient who expired was 64 years old, reason for hospital admission: deterioration of general condition and shock (cardiogenic + suspected septic), tazocin on admission, switch vancomycin + clamoxyl + fluconazole.There is no link between the patient's death and the diagnostic error.

Manufacturer Narrative

H6: investigation summary: catalog: 442022.Batch no.: 2102632.Customer reported a contamination issue while using bactec product.Neither photos nor returned good samples were received.Bd was unable to reproduce the customer¿s experience with bactec product.Retention 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 samples and batch history 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.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.

Event Description

Report 1 of 3.It was reported that during use with the bd bactec¿ plus anaerobic/f culture vials (plastic), a vial was contaminated with lactobacillus paracasei.Erroneous results were reported to the clinician, and the patient was treated based on the erroneous results.The patient expired 21 days later, but there is no indication that the bd product caused or contributed to the patient death.The following information was provided by the initial reporter, translated from french: for the last week, we have observed a strangely high number of blood cultures positive to lactobacillus paracasei (all with the same antibiogram).Additional information received on 01/aug/2022: cause of death: persistence of a biological inflammatory syndrome, fever with hypotension on (b)(6), unilateral cervical contracture without meningeal stiffness; death observed a few hours after this note change in treatment of patient who expired happened on 26/6, then he died on 16/07 the patient who expired was 64 years old, reason for hospital admission: deterioration of general condition and shock (cardiogenic + suspected septic), tazocin on admission, switch vancomycin + clamoxyl + fluconazole.There is no link between the patient's death and the diagnostic error.

• Brand Name: BD BACTEC¿ PLUS 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
• 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: 15158115
• MDR Text Key: 297184753
• Report Number: 2647876-2022-00174
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420222
• UDI-Public: 00382904420222
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K141810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Model Number: 442022
• Device Catalogue Number: 442022
• Device Lot Number: 2102632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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
• Patient Age: 64 YR
• Patient Sex: Male