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

Model Number 442021

Device Problems Fluid/Blood Leak (1250); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2021

Event Type  malfunction  

Event Description

It was reported while testing with bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) there was contamination of biological material.Only one bottle broke.There was no report of patient impact.The following information was provided by the initial reporter: broken bottle when taking out of the bactec fx instrument.The mentioned bactec bottle became positive.When unloading the bottle, the bottle was broken.Probably the bottle was already damaged before the bottle was loading into the instrument.The broken bottle was positive for contaminants.As for the same patient 3 other bottles were declared negative, the broken bottle was also considered as negative.No incorrect results were reported to the clinician and/or patients.

Manufacturer Narrative

The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation: bd was unable to reproduce customer¿s experience with the bactec product for leakage/damage defect.One photo of a damage plastic bottle was received.Satisfactory results were obtained from retention samples when visually inspected.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 confirmed based on photo received from the customer.A technical assessment was performed by the engineering department to determine if the optima filling line had mechanical issues and/or breakdowns during the manufacturing process of the aforementioned batch.Investigation revealed that preventive maintenance to the optima filling line machine was completed on time as scheduled.Upon evaluation of breakdowns / incidents reports, there were no malfunctions reported related to cap seal.Cap vision inspection system is challenged prior each lot.No trend has been identified for reported defect.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

It was reported while testing with bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) there was contamination of biological material.Only one bottle broke.There was no report of patient impact.The following information was provided by the initial reporter: broken bottle when taking out of the bactec fx instrument the mentioned bactec bottle became positive.When unloading the bottle, the bottle was broken.Probably the bottle was already damaged before the bottle was loading into the instrument.The broken bottle was positive for contaminants.As for the same patient 3 other bottles were declared negative, the broken bottle was also considered as negative.No incorrect results were reported to the clinician and/or patients.

• 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
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12824572
• MDR Text Key: 287808038
• Report Number: 3008352382-2021-00189
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420215
• UDI-Public: 00382904420215
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K123903
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: 442021
• Device Catalogue Number: 442021
• Device Lot Number: 1132357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2021
• 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