MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY BROTH WITH 20% GLYCEROL; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Catalog Number 221823

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/24/2023

Event Type  malfunction  

Manufacturer Narrative

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 bd bbl¿ trypticase¿ soy broth with 20% glycerol contamination occurred to 20% of tubes from about 2 case of 100 tubes.The following information was provided by the initial reporter: customer reports media 297352 contaminated and loose cap - approximate quantity of product received in shipment? 2 cases of 100 tubes.- approximate quantity of product contaminated and loose cap? 20% contaminated tubes, loose caps undetermined ¿ would require 100% inspection.

Event Description

It was reported that bd bbl¿ trypticase¿ soy broth with 20% glycerol contamination occurred to 20% of tubes from about 2 case of 100 tubes.The following information was provided by the initial reporter: customer reports media 297352 contaminated and loose cap.Approximate quantity of product received in shipment? 2 cases of 100 tubes.Approximate quantity of product contaminated and loose cap? 20% contaminated tubes, loose caps undetermined ¿ would require 100% inspection.

Manufacturer Narrative

H.6.Investigation summary: the batch history review for batch: 3187521 was satisfactory per internal procedures.Formulation, filling, torquing, and autoclaving processes were within specifications.In process checks were performed at the designated intervals.Those checks confirmed that the caps were tightened to the validated specifications per internal procedure.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 there are no other complaints on batch: 3187521.Retention samples (10) were available for inspection.There were 0/10 contamination defects observed and 0/10 cap defect/loose cap defects observed in the retention tubes from visual inspection.Two (2) uninoculated retention tubes were placed into incubation to test for contamination.One tube was placed into the 20 to 25 degrees celsius incubator and one tube was placed into the 33 to 37 degrees celsius incubator.At seven days (7) incubation, there were no traces of microbial growth in the incubated retention tubes nor change in media appearance.Seven (7) photos were received to assist in the investigation of batch: 3187521.Three photos show the carton label batch: 3187521.Four photos show a 100-tube rack with visible turbid tubes batch: 3187521.Returns were received to assist with the investigation in a large shipping box packed with tissue paper and air bubbles.One bd 100 pack carton batch: 3187521, carton#: (b)(4) was received and contained sticky tubes with media spillage and liquid damage along with dried stains.All 100 tubes felt sticky to the touch.There were 55 tubes low filled and contaminated.Two of these tubes had low fill and loose caps, as well as turbid media and contamination.One of the 55 tubes were low filled, loose caps, had turbid media and contamination and no label.All 55 tubes had dried media under the cap on the thread of the tube from leaking media.Forty-five returned tubes did not have loose caps, turbid media, visible contamination nor fill volume defects and were incubated for seven days.Twenty-three (23) tubes were incubated at 20 to 25 degrees celsius and twenty-two (22) tubes were incubated at 33 to 37 degrees celsius.At 7 days, there was no microbial growth or change in media color or clarity.This complaint can be confirmed for contamination based on the photos and returns and loose caps based on the returns.No complaint trends for these defects have been identified for this product; no actions are indicated at this time.Bd will continue to trend complaints for contamination and cap defects.The following fields have been updated with additional/corrected information: d.4.Device available for eval: yes.D.4.Returned to manufacturer on: 2024-mar-15.

• Brand Name: BD BBL¿ TRYPTICASE¿ SOY BROTH WITH 20% GLYCEROL
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• 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: 17674498
• MDR Text Key: 323072047
• Report Number: 1119779-2023-00968
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 30382902218235
• UDI-Public: 30382902218235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 03/18/2024

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: 221823
• Device Lot Number: 3187521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/01/2023
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2023
• 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