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

Model Number 297354

Device Problem Contamination (1120)

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

Event Date 11/16/2021

Event Type  malfunction  

Event Description

It was reported that one bd bbl¿ trypticase¿ soy broth tube was contaminated with bacteria.There was no report of patient impact.The following information was provided by the initial reporter: customer reports tube with contamination.

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that one bd bbl¿ trypticase¿ soy broth tube was contaminated with bacteria.There was no report of patient impact.The following information was provided by the initial reporter: customer reports tube with contamination.

Manufacturer Narrative

H6: investigation summary.This memo is to summarize findings regarding the complaint related to, catalog number 297354, tube trypticase soy broth 10ml 100ea, batch number 1222911 for contamination and cosmetic defects.Material 297354 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 1222911 was satisfactory and no quality notifications were generated during manufacturing and inspection.In process checks are performed during manufacturing at designated intervals per procedures.Those checks confirmed that the caps were tightened to the validated specifications per internal procedure and fill volumes were within specification.Qc inspection and testing were satisfactory at time of release.As part of the release criteria for this product, the bhrs are 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 for fill volume or cap defects.One other complaint has been taken for contamination.Retention samples from batch 1222911 (10 tubes) were available for inspection.No defects were observed in 10/10 retention samples.No looses caps were observed in 10/10 retention samples.All 10 retention tubes measured at 10ml.No low fill volume was observed in 10/10 retention sample tubes.For further investigation, two retention tubes were tested for contamination.One tube was place in the 20¿25-degree celsius incubator.One tube was placed into the 33¿37-degree incubator.There was no microbial growth or turbidity of the media observed in either tube at either temperature within an eight-day incubation period.Two photos were received to assist with the investigation.The first photo shows one tube from batch 1222911.The media in the photo does appear hazy.There also appear to be a large white mass (possibly fungal) on the side of the tube.The fill volume appears lower than expected.The second photo also shows one tube from batch 1222911.The media in the photo does appear hazy.There also appear to be a large white mass (possibly fungal) on the side of the tube.The fill volume appears lower than expected.No returns were received to assist with the investigation.This complaint cannot be confirmed for cap defects.This complaint can be confirmed for contamination and fill volume.A defect trend has not been identified, therefore, there are no actions planned at this time.Bd will continue to trend complaints for contamination, packaging, and fill volume.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13005014
• MDR Text Key: 288033994
• Report Number: 1119779-2021-01961
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 30382902973547
• UDI-Public: 30382902973547
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 02/18/2022

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: 02/08/2023
• Device Model Number: 297354
• Device Catalogue Number: 297354
• Device Lot Number: 1222911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 02/18/2022
• Supplement Dates FDA Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2021
• 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