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

Model Number 245122

Device Problem Labelling, Instructions for Use or Training Problem (1318)

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

Event Date 03/10/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: 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 bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml one tube was found to be missing a label.The following information was provided by the initial reporter: mycobacterium culture tubes were found to have quality problems 1 no label.

Event Description

It was reported that bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml one tube was found to be missing a label.The following information was provided by the initial reporter: mycobacterium culture tubes were found to have quality problems 1 no label.

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 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 2019007 was satisfactory per internal procedures.Formulation and filling processes were within specifications.In process checks were performed during manufacturing at designated intervals per procedures.Checks for fill volume were complete and within specifications per procedures and checks for torque confirmed that the caps were tightened to the validated specifications per internal procedure.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other complaints have been taken on this batch.Retention samples from batch 2019007 (100 tubes) were available for inspection.No defects were observed in 100/100 retention samples.No leaking or labeling defects were observed in 100/100 retention tubes.All 100/100 retention tubes were measured using a fill volume measuring tool.All 100/100 retention tubes had properly affixed legible and scannable barcode labels.Two videos were received to assist with the investigation: the first video shows one partial tube from batch 2019007 (the bottom of the tube cannot be seen in the video.The media fill appears to be as expected in this video.The determination of a leaking tube in this video cannot be determined.The second photo shows one tube without any labels.No returns were received to assist with the investigation.The complaint cannot be confirmed for a leaking tube based on the evidence provided by the videos received.The complaint can be confirmed for a tube missing a label based on the evidence provided by the videos received.No complaint trends for this defect has been identified for this product ;no actions are indicated at this time.Bd will continue to trend complaints for leaking tubes, and missing labels.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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16698888
• MDR Text Key: 312867568
• Report Number: 1119779-2023-00403
• 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: 04/21/2023

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: 07/16/2023
• Device Model Number: 245122
• Device Catalogue Number: 245122
• Device Lot Number: 2019007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 04/07/2023
• Supplement Dates Manufacturer Received: 04/21/2023
• Supplement Dates FDA Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1