MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Model Number 221788

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/23/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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¿ thioglycollate medium, enriched with vitamin k1 and hemin 2 boxes were received and contamination occurred.No injuries were reported.The following information was provided by the initial reporter: when product arrived packaging was acceptable.Product was cloudy.Gram stain confirmed that the product is contaminated.

Event Description

It was reported that bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin 2 boxes were received and contamination occurred.No injuries were reported.The following information was provided by the initial reporter: when product arrived packaging was acceptable.Product was cloudy.Gram stain confirmed that the product is contaminated.

Manufacturer Narrative

H.6 investigation summary material 221788 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 2244936 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, 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 was 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 other complaints for contamination/non-viables.Retention samples from batch 2244936 (10 tubes) were available for inspection.No media defects such as contamination/turbid media were observed in 10/10 retention samples.All retentions tubes had the expected appearance for this product of light to medium light yellow, trace hazy to clear.For investigation, two retention tubes went into incubation.One retention tube was incubated in the 20-25 degree celsius incubator and the other tube was placed in the 33-37 degree celsius incubator.At the seventh day of incubation there were no signs of growth or turbidity.A gram stain was also performed on the retention sample and no organism was found.Two photos were received to assist with the investigation: the first photo shows one tube from batch 2244936, the media does appear cloudy/turbid.The second photo shows the label of two partial cartons from batch 2244936 carton number 0332 and the second carton number 0319.Returns were received to assist with the investigation.A taped bd carton from batch 2244936 (carton number 0319) in a medium shipping package was received with tissue paper.There were 100 tubes from batch 2244936 in the carton.All 100/100 tubes the media did appear cloudy.All 100/100 returned tubes were incubated at 33-37-degrees celsius.There was no change in the media, a gram-stain was performed and non-viable gram-variable rods were observed.This complaint can be confirmed based on the evidence provided by the photos and returns received.Bd will continue to trend complaints for contamination/non-viables.Caution should be exercised in reporting direct gram stain and/or other direct microbiological stain results on tissue specimens processed with this medium due to the possible presence of nonviable organisms in the culture medium.Culture media sometimes contain dead organisms derived from medium constituents, which may be visible in smears of culture media.If there is uncertainty about the validity of the gram stain, the culture should be re-incubated for another hour or two and the test repeated before a report is given.The returns and photos for this batch showed visible sediment that was determined to be non-viable organisms.The amount of sediment in tubes, when distributed throughout the media, makes the media appear hazy and is outside of the clarity specification, of light to medium light yellow, trace hazy to clear for this product.While non-viables are possible in the media, the amount observed has created an appearance defect.A complaint trend was not identified for contamination, including non-viables, or appearance in this product per bd procedures.No actions are required for this defect at this time.However, bd strives to improve.A cross-functional team has been engaged to investigate the manufacturing and inspection process of this product with respect to possible non-viable contamination and hazy appearance of the media.Potential manufacturing and quality testing improvements have been identified and are in process.Bd expects to see less haziness due to non-viables in future batches as improvements are implemented.

• Brand Name: BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN
• 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 ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 16042955
• MDR Text Key: 306838411
• Report Number: 1119779-2022-01536
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K803023
• 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: 02/27/2023

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: 08/30/2023
• Device Model Number: 221788
• Device Catalogue Number: 221788
• Device Lot Number: 2244936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1