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

Catalog Number 245122

Device Problems Device Markings/Labelling Problem (2911); Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/11/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: metro manila don euqenio sr.Medical complex,ortigas ave, 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 one bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml is contaminated and had no label.No patient impact was reported.The following information was provided by the initial reporter: 1 mgit tube is contaminated and another one has no sticker label.

Event Description

It was reported that one bd bbl¿ mgit¿ mycobacteria growth indicator tubes, 7ml is contaminated and had no label.No patient impact was reported.The following information was provided by the initial reporter: 1 mgit tube is contaminated and another one has no sticker 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 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 2188093 was satisfactory per internal procedures.Formulation, filling, torquing, labeling, and autoclaving processes were within specifications.Qc inspection and testing were satisfactory at time of release.As part of the release criteria for this product, the bhr is reviewed to confirm the following: the total elapsed time between end of formulation and start of the autoclave cycle was within the specified limits.All autoclave parameters conformed to the validated cycle parameters for this product.The minimum f0 for this product was met.The complaint history was reviewed, and two other complaints have been taken on this batch for contamination, and one other complaint has been taken on this batch for labeling.Retention samples from batch 2188093 (100 tubes) were available for inspection.All 100/100 retention samples had properly affixed, legible labels and scannable barcode labels.The retention samples showed no signs of turbidity or contamination in 100/100 retention tubes.For further investigation 10 retention tubes were incubated.Five tubes were placed into 33-37-degrees celsius incubation, and five tubes were placed into 20-25-degrees celsius incubation.At the end of a seven-day incubation period no microbial growth was observed in 10/10 incubated retention tubes.One photo was received to assist with the investigation: the photo shows two tubes from batch 2188093.The tube on the left appears to be contaminated possibly fungal growth.The tube on the right is missing a label.No returns were received to assist with the investigation.This complaint can be confirmed based on the evidence provided by the photo received.No complaint trends for this defect have been identified for this product; no 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: 17621134
• MDR Text Key: 321924176
• Report Number: 1119779-2023-00941
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 30382902451229
• UDI-Public: 30382902451229
• Combination Product (y/n): N
• Reporter Country Code: RP
• 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: 10/14/2023

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: 12/31/2023
• Device Catalogue Number: 245122
• Device Lot Number: 2188093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 10/14/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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