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 Missing Information (4053)

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

Event Date 10/12/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bottle of a bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) was missing the label.The following information was provided by the initial reporter, translated from (b)(6) to english: one bottle without label was returned by the customer.

Event Description

It was reported that the bottle of a bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) was missing the label.The following information was provided by the initial reporter, translated from chinese to english: one bottle without label was returned by the customer.

Manufacturer Narrative

H6: investigation summary bd was unable to reproduce customer experience with the bactec product.One out of three photos provided showed a plastic bottle without vial label.Satisfactory results were obtained from retention samples when visually inspected for reported defect (no vial label).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.An engineering technical assessment was performed to determine if the wailer bottle labeler had any mechanical issues and/or breakdowns on the labeling process of aforementioned batch.Investigation revealed that preventive maintenance to the machine was completed on time as scheduled.Upon evaluation of breakdowns / incidents reports, there were no issues reported for vials without label reported on that date.After evaluating the production reports, issues were reported on the weiler labeler machine related with several jams and machine out of synchronization.As part of the corrective¿s actions, a training was provided to the engineering technicians for specific instructions for the synchronization interventions on the weiler labeler machine.As a preventive action, a change control was initiated to add new redundant label inspection system to ensure the presence of the vial label.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¿ 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: 12775569
• MDR Text Key: 285463637
• Report Number: 2647876-2021-00268
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420215
• UDI-Public: 00382904420215
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123903
• 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: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: 442021
• Device Catalogue Number: 442021
• Device Lot Number: 1153222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2021
• 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