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 Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/04/2023

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 was found contaminated.No patient impact was reported.The following information was provided by the initial reporter: customer reports tsb 221093__3129898 contamination.

Event Description

It was reported that bd bbl¿ trypticase¿ soy broth was found contaminated.No patient impact was reported.The following information was provided by the initial reporter: customer reports tsb 221093__3129898 contamination.

Manufacturer Narrative

H.6 investigation summary: 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 3129898 was satisfactory per internal procedures.Formulation, filling, torqueing, 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 no other complaints have been taken on this batch.Retention samples from batch 3129898 (10 tubes) were available for inspection.No signs of turbidity or contamination were observed in 10/10 retention tubes.Two uninoculated retention tubes were incubated.One tube was incubated at 33-37-degrees celsius, and one retention tube was incubated in at 20-25 degree celsius.At seven days incubation, no microbial growth was observed in 2/2 tubes.Two photos were received to assist with the investigation.The first photo shows the bottom of a tube with the media featured.The media does appear hazy in clarity with possible growth.The second photo is a micrograph labeled as wet mount with rod-shaped organisms seen.Returns also were received to assist with the investigation.Four tubes from batch 3129898 in a plastic bag were returned in a mailer envelope with paper towel padding.The tubes were not labeled or marked from usage.The media returned was hazy in 4/4 tubes.For investigation, all four returned tubes were incubated at 33-37-degrees celsius.At seven days incubation, the media clarity did not change (was not hazier) and there was no microbial growth observed.The media was gram stained and gram negative rods were observed.The haziness of the media is caused by non-viable organisms.The clarity specification for this product is clear to trace hazy.The return samples and tube in the photo has media that is more than trace hazy.Media that is outside of the appearance specification should not be used.Caution should be exercised in reporting direct microbiological stain or molecular testing directly using this medium due to the possible presence of non-viable organisms in the culture medium.Culture media sometimes contain dead organisms derived from medium constituents, which may be visible in smears of culture media or detectible by molecular testing.Product should not be used if medium shows evidence of contamination, discoloration, drying or other signs of deterioration.This complaint can be confirmed.Bd has identified a complaint trend for hazy media due to the presence of non-viables for this product.

• 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: 17553715
• MDR Text Key: 321750358
• Report Number: 1119779-2023-00896
• 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: 09/18/2023

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: 3129898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/15/2023
• Supplement Dates Manufacturer Received: 09/18/2023
• Supplement Dates FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2023
• 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