MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML; SYSTEM, BLOOD CULTURING

Model Number 245122

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 03/15/2022

Event Type  malfunction  

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 has been reported that the bd bbl¿ mgit¿ mycobacteria growth indicator tube has been found with no label.The following has been provided by the initial reporter: customer opened the box and found out some tubes have no label on this.They refused to use this boxed in testing sample.

Manufacturer Narrative

H6.Investigation summary: this memo is to summarize findings regarding the complaint related to catalog number 245122, tube bactec mgit 7ml, batch number 1056383 and complaint number (b)(4)for missing labels.Material 245122 is manufactured by rehydrating the media components with usp purified water and thoroughly mixing until a homogeneous solution is obtained.The tubes are filled, capped, torqued and then labeled by machine per standard operating procedure (sop).The tubes are terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, tubes are packaged into final shipping configurations.The batch history record review for batch 1056383 was satisfactory per internal procedures.Filling, labeling, and packaging processes were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other complaint have been taken on this batch.Retention samples from batch 1056383 (100 tubes) were available for investigation.Tubes were inspected and all 100/100 retention tubes from batch 1056383 were found to have properly affixed and legible labels.Two photos were received to assist with the investigation: ¿ the first photo shows the label from a partial bd carton from batch 1056383.¿ the second photo shows five tubes in a tube rack with no label.No returns were received for investigation.This complaint has been confirmed based on the photos received.A trend has not been identified, therefore, no actions are planned at this time.Bd will continue to trend complaints for labeling.If there are further questions, please contact technical services.

Event Description

It has been reported that the bd bbl¿ mgit¿ mycobacteria growth indicator tube has been found with no label.The following has been provided by the initial reporter: customer opened the box and found out some tubes have no label on this.They refused to use this boxed in testing sample.

• Brand Name: BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES, 7ML
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14077829
• MDR Text Key: 298591442
• Report Number: 1119779-2022-00550
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: 30382902451229
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K974883
• 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: 06/26/2022

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: 08/20/2022
• Device Model Number: 245122
• Device Catalogue Number: 245122
• Device Lot Number: 1056383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: 06/26/2022
• Supplement Dates FDA Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2021
• 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