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

Catalog Number 442023

Device Problem Missing Information (4053)

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

Event Date 09/17/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 during use with bd bactec¿ plus aerobic/f culture vials (plastic) the label was partially missing on the bottle.The following information was provided by the initial reporter: the bactec plus aerobic/f bottles has loss sticker barcode.The customer has concern about the quality of a bactec bottle from this lot.

Manufacturer Narrative

H.6.Investigation summary: customer reported a missing vial label.Photos of missing vial label were received.Bd was unable to reproduce customer experience with the bactec product.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 weiler bottle labeler had any mechanical issues and/or breakdowns on the labeling process of aforementioned batch.Investigation revealed that preventive maintenance (pm) to the machine was completed on time as scheduled.Upon evaluation of breakdowns / incidents reports, there were issues reported of label placement.After evaluating the production reports, issues were reported on the weiler labeler machine related with several jams, adjustments, and machine out of synchronization.Corrective actions were implemented during the labeling process.A pm was performed, and the equipment was found to be working as expected.No trend was identified for this defect.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 that during use with bd bactec¿ plus aerobic/f culture vials (plastic) the label was partially missing on the bottle.The following information was provided by the initial reporter: the bactec plus aerobic/f bottles has loss sticker barcode.The customer has concern about the quality of a bactec bottle from this lot.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17916726
• MDR Text Key: 326065577
• Report Number: 3008352382-2023-00188
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420239
• UDI-Public: 00382904420239
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K113558
• 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: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/27/2023
• Device Catalogue Number: 442023
• Device Lot Number: 3081935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 11/26/2023
• Supplement Dates FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2023
• 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