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 12/01/2021

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 labels were missing from bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml.This occurred with 10 tubes.The following information was provided by the initial reporter, translated from (b)(6) to english: the tube does not have any labeling stickers.

Event Description

It was reported that the labels were missing from bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml.This occurred with 10 tubes.The following information was provided by the initial reporter, translated from chinese to english: the tube does not have any labeling stickers.

Manufacturer Narrative

H.6.Investigation: 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 1191962 was satisfactory per internal procedures.Formulation, filling, and packaging processes were within specifications.In process checks were performed at the designated intervals.Those checks confirmed that the caps were tightened to the validated specifications per internal procedure.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 1191962 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 either defect has been taken on this batch.Retention samples from batch 1191962 (100 tubes) were available for inspection.No cap, or tube defects were observed in 100/100 retention samples.All 100/100 retention tubes had a properly affixed tube label.One photo was received to assist with the investigation: the photo shows four tubes laying on a counter.Three tubes still have the cap on the tube.One tube the cap is missing.All four tubes are missing a label.No product information is presented in the photo.A photo alone cannot confirm a complaint.A photo must have product information such as batch number, or a product carton which must show the product label so that the batch number and product information is presented.No returns were received to assist with the investigation.This complaint cannot be confirmed for either defect.Bd will continue to trend complaints for cap defects, labeling, and packaging.

• 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: 13114490
• MDR Text Key: 288185268
• Report Number: 1119779-2021-02060
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: 30382902451229
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K974883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

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: 01/01/2023
• Device Model Number: 245122
• Device Catalogue Number: 245122
• Device Lot Number: 1191962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 05/12/2022
• Supplement Dates FDA Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2021
• 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