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

Model Number 245122

Device Problem Missing Information (4053)

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

Event Date 10/06/2021

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 7 bd bbl¿ mgit¿ mycobacteria growth indicator tubes had no label on them.The following information was provided by the initial reporter, translated from chinese to english: "mgit tube has no identifiable label.".

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 1063895 was satisfactory per internal procedures.Filling, labeling and packaging processes were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and three other complaints have been taken on this batch for labeling.Retention samples from batch 1063895 (100 tubes) were available for inspection.No labeling defects were observed in 100/100 retention samples.All retention tubes had one tube label that had legible batch information and a scannable barcode.No photos were received to assist with the investigation.No returns were received to assist with the investigation.This complaint cannot be confirmed.Bd will continue to trend complaints for labeling.

Event Description

It was reported that 7 bd bbl¿ mgit¿ mycobacteria growth indicator tubes had no label on them.The following information was provided by the initial reporter, translated from chinese to english: "mgit tube has no identifiable label".

• Brand Name: BD BBL¿ MGIT¿ MYCOBACTERIA GROWTH INDICATOR TUBES
• Type of Device: BLOOD CULTURING SYSTEM
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12745943
• MDR Text Key: 279883454
• Report Number: 1119779-2021-01751
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/02/2022
• Device Model Number: 245122
• Device Catalogue Number: 245122
• Device Lot Number: 1063895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2021
• 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