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

Catalog Number 221093

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 08/03/2023

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 prior to using bd bbl¿ trypticase¿ soy broth, there was biological contamination of 4 tubes.No patient impact reported.The following information was provided by the initial reporter: "customer reporting contamination and evaporation of product 221093 lot no.3096339.One looks to be fungal, and the other contaminated tube looks to be bacterial.".

Manufacturer Narrative

The following fields have been updated with corrected and/or additional information.D9: device available for evaluation: yes d9: returned to manufacturer on: 16-aug-2023.H.6.Investigation summary: this memo is to summarize findings regarding the complaint related to catalog number 221093, tube trypticase soy broth 8 ml 100 ea, batch number 3096339 and bd complaint number 8581643 for contamination and low fill volume.Material 221093 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 3096339 was satisfactory per internal procedures.Formulation, filling, torqueing, and autoclaving processes were within specifications.In process checks were performed during manufacturing at designated intervals per procedures.All checks for fill volume were complete and within specifications per procedures and checks for torque were complete and within limits.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 no other complaints have been taken on batch 3096339.Retention samples from batch 3096339 (10 tubes) were available for inspection.No contamination or low fill volume was observed in 10/10 retention samples.For further investigation, two retention tubes were incubated.One retention tube was incubated at 33 to 37 degrees celsius, and one retention tube was incubated at 20 to 25 degrees celsius.Both tubes had no microbial growth at seven days of incubation.One photo was received to assist with the investigation.The photo shows six tubes from batch 3096339.Five tubes have lower than expected fill volume and one tube with low fill also appears to have growth.It is also observed that there is moisture damage and stains on the tube label and what appears to be dried media drips on the outside of the tubes.All of these observations combined may point to leaking media.Returns were received to assist with the investigation.Ten tubes from batch 3096339 were received wrapped in bubble wrap inside of a plastic bag shipped in a fedex shipping box.Five out of the ten returned tubes received had less than expected media.Of those tubes with less than expected media, 2/5 also had contamination.Both contaminated tube were submitted to the id lab and cytobacillus oceanisediminis and malbranchea species were identified.For further investigation, the eight returned tubes that were not contaminated were incubated.Four returned tubes were incubated at 20-25-degrees celsius, and four returned tubes were incubated at 33-37-degrees celsius.At seven days incubation, 0/8 tubes had microbial growth.It is noted moisture damage and media stains were seen on some of the returned tubes labels and that the outside of the tubes were sticky with dried media.Though no loose caps were observed directly in the returns, the combined observations of low fill volume, contamination, moisture damaged and stained labels, and dried media on the outside of the tubes indicate leaking media.The contamination and low fill volume observed in the tubes was caused by media leaking from the tubes.This complaint can be confirmed for leaking media.Contamination was not observed in return samples that did not have low fill volume.No complaint trend for leaking media has been identified for this product; no actions are indicated at this time.

Event Description

It was reported that prior to using bd bbl¿ trypticase¿ soy broth, there was biological contamination of 4 tubes.No patient impact reported.The following information was provided by the initial reporter: "customer reporting contamination and evaporation of product 221093 lot no.3096339.One looks to be fungal, and the other contaminated tube looks to be bacterial.".

• Brand Name: BD BBL¿ TRYPTICASE¿ SOY BROTH
• 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: 17515898
• MDR Text Key: 321110224
• Report Number: 1119779-2023-00882
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 30382902210932
• UDI-Public: 30382902210932
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• 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: 09/22/2023

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: 221093
• Device Lot Number: 3096339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 09/22/2023
• Supplement Dates FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2023
• 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