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 07/07/2023

Event Type  malfunction  

Manufacturer Narrative

There were two lot numbers reported to be involved.The information for each additional lot number is as follows: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot#: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.H.3.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 prior to using bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml, the customer found two unlabeled tubes for lot 2325740.In a separate occurrence, an unknown quantity of tubes for an unknown lot were unlabeled.No patient impact reported.The following information was provided by the initial reporter: "tubes not labeled.Found 2 unlabeled mgit tubes in a box.This has occurred previously but decided to submit product complaint now.".

Event Description

It was reported that prior to using bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml, the customer found two unlabeled tubes for lot 2325740.In a separate occurrence, an unknown quantity of tubes for an unknown lot were unlabeled.No patient impact reported.The following information was provided by the initial reporter: "tubes not labeled.Found 2 unlabeled mgit tubes in a box.This has occurred previously but decided to submit product complaint now.".

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-july-18.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.Batch 2325740.The batch history record review for batch 2325740 was satisfactory and no quality notifications were generated during manufacturing and inspection.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 complaints have been taken on batch 2325740.Retention samples from batch 2325740 (100 tubes) were available for inspection.No labeling defects were observed in 100/100 retention samples.All 100/100 retention tubes had one properly affixed and legible tube and a scannable barcode label.Unknown batch customer did not provide a batch number, photos or returns for this batch.Trending was done on the appropriate databases for bactec mgit 7ml (material 245122) and no quality notification trends have been identified for this material for labeling defects in the last 12 months.The complaint history was reviewed for material 245122 and there are no trends for labeling defects in the last 12 months.Bd will continue to trend complaints for this issue.This complaint cannot be confirmed based on material trending.One photo was received to assist with the investigation: the photo shows a partially opened bd 100-pack carton from batch 2325740; the carton appears to have been used.Three partial tubes were pulled from the carton one tube is properly labeled and two tubes are missing labels.The tubes are from batch 2325740.No returns were received to assist with the investigation.This complaint can be confirmed for missing labels for batch 2325740 based on the photo provided.The complaint cannot be confirmed for the unknown batch based on material trending.Bd will continue to trend complaints for labeling defects such as missing labels.No additional actions are indicated at this time.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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17401544
• MDR Text Key: 319887300
• Report Number: 1119779-2023-00810
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: 30382902451229
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K974883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2023

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: 05/19/2024
• Device Catalogue Number: 245122
• Device Lot Number: 2325740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• 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