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

Catalog Number 245122

Device Problem Missing Information (4053)

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

Event Date 07/17/2023

Event Type  malfunction  

Event Description

It was reported that while using bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml that there was no label or missing label information in 3 tubes.The following information was provided by the initial reporter: three tubes came without the barcode label.Three tubes came without the barcode label and one tube came with a volume of less than 7ml.

Manufacturer Narrative

E.7 initial reporter addr 1:(b)(6).H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for evaluation: yes.D.9:device eval by manufacturer? yes.D9: returned to manufacturer on: 2023-september- 06.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 2265557 was satisfactory per internal procedures.Formulation, filling, labeling, 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 2265557 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 complaints for labeling have been taken on this batch.Retention samples from batch 2265557 (100 tubes) were available for inspection.No labeling defects were observed in 100/100 retention samples.All 100/100 retention tubes had a properly affixed, legible, labels and a scannable barcode label.Three photos were received to assist with the investigation: the first photo shows some tubes rubber banded together from batch 2265557.The second and third photos show four tubes from batch 2265557.Three tubes do not have a label, and the fill volume on one tube is lower than expected.No returns were received to assist with the investigation.This complaint can be confirmed.No complaint trends for this defect have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for labeling defects.

Event Description

It was reported that while using bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml that there was no label or missing label information in 3 tubes.The following information was provided by the initial reporter: three tubes came without the barcode label.Three tubes came without the barcode label and one tube came with a volume of less than 7ml.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17443010
• MDR Text Key: 320225088
• Report Number: 1119779-2023-00826
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: 30382902451229
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 09/07/2023

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: 03/17/2024
• Device Catalogue Number: 245122
• Device Lot Number: 2265557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 09/07/2023
• Supplement Dates FDA Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2022
• 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