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

Catalog Number 245122

Device Problem Microbial Contamination of Device (2303)

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

Event Date 10/11/2023

Event Type  malfunction  

Event Description

It was reported that while using bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml, there was biological contamination seen across multiple lot numbers.No patient impact reported.The following information was provided by the initial reporter: "customer reporting contamination for product 245122.Contamination issues was with positive cocci and positive bacilli.White grey colony.I gram the tube with the most growth in it and i saw gram + cocci.That tube was from a new box.Customer had this issue with multiple lot number but only 3096353 they have details.2195042- unable to get information, 2321502-unable to get information, 2349930-unable to get information, 2342598-unable to get information, 3096353 -only this they have detail.

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot#: 2195042, d4.Medical device expiration date: 07-01-2024, h4.Device manufacture date: 07-14-2022.D4.Medical device lot#: 2321502, d4.Medical device expiration date: 19-05-2024, h4.Device manufacture date: 17-11-2022.D4.Medical device lot#: 2349930, d4.Medical device expiration date: 15-06-2024, h4.Device manufacture date: 15-12-2022.D4.Medical device lot#: 2342598, d4.Medical device expiration date: 08-06-2024, h4.Device manufacture date: 08-12-2022.D4.Medical device lot#: 3096353, d4.Medical device expiration date: 06-10-2024, h4.Device manufacture date: 06-04-2023.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

• 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: 18006260
• MDR Text Key: 326527944
• Report Number: 1119779-2023-01178
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382902451228
• UDI-Public: (01)00382902451228
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 10/19/2023

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 Catalogue Number: 245122
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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