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 06/27/2022

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 was reported that while using 4 bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml missing label information was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: in the experiment, four culture tubes of mycobacterium l (art.245122, lot.1279803, validity 2023-4-5) were found without labels.

Event Description

It was reported that while using 4 bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml missing label information was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "in the experiment, four culture tubes of mycobacterium l (art.245122, lot.1279803, validity 2023-4-5) were found without labels.".

Manufacturer Narrative

H.6 investigation summary: 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 was satisfactory per internal procedures.Formulation, filling, and packaging processes were within specifications.The labeling process for material 245122 includes label reconciliation where the total number of labels issued is reconciled with the total quantity of labels applied to tubes, used in the batch history record, rejected and unused.Any discrepancies must be within allowable limits specified in the labeling control procedure.The label reconciliation for batch 1279803 does not show an excess of labels after manufacturing which would support the incidence of a tube without a label.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other complaint has been taken on this batch.Retention samples from batch 1279803 (100 tubes) were available for inspection.No labeling defects were observed in 100/100 retention samples.All retention tubes had a properly affixed tube label and scannable barcode labels.Three photos were received to assist with the investigation: the first photo shows a partial carton with a label for batch 1279803.The second photo shows a bd closed carton from batch 1279803.The last photo shows three tubes without any labels on them.The complaint can be confirmed.No actions are indicated at this time as no trends were observed.Bd will continue to trend complaints for missing tube labels.Notes: risk management review indicates the potential risk of the defect reported was assessed as severity [s1], per [baltrmlmbactecmgitaph, rev [03], id [6.2].H3 other text : see h.10.

• 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: 15089188
• MDR Text Key: 297916137
• Report Number: 1119779-2022-01019
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: 30382902451229
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/05/2023
• Device Model Number: 245122
• Device Catalogue Number: 245122
• Device Lot Number: 1279803
• 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: 10/06/2021
• 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