MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN; MULTIPURPOSE CULTURE MEDIUM

Catalog Number 221788

Device Problems False Negative Result (1225); Microbial Contamination of Device (2303)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2019

Event Type  malfunction  

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 while using bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin for culturing 3 patient samples the lab observed non-viable organisms present in the media.The media was used for 1 blood culture and 2 sterile site cultures.The results were erroneously reported as gram-negative rods for 3 patients.No information was available on how the patient treatment was changed or if treatment was changed.No misdiagnosis or worsening in patient condition was indicated.

Manufacturer Narrative

Investigation summary: this product 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 9107669 was satisfactory and no notifications were generated during manufacturing and inspection.Formulation, filling and autoclaving processes were within specifications.Qc inspection and testing were satisfactory at time of release.The release testing that is performed on this product does include review of its color and clarity.Samples submitted are examined to ensure that they conform to typical levels.The appearance of this batch was satisfactory per internal procedures.Direct staining techniques are not part of qc release testing for this product.Additionally 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 other complaints, including a second from this customer for a different shipment, have been taken on this batch for appearance but are also unconfirmed.Retention samples from batch 9107669 were available for inspection.No cap, tube or media defects were observed in 10/10 retention tubes.No appearance defects or microbial growth were found in the retention samples.Three photos were received for investigation.The first photo features a carton label from batch 9107669 (carton 0683) for batch verification.The second photo shows the side of nine 100pack cartons and one tube packaging rack that appears to be full.The third photo shows the top of the full packaging rack.No defects are obvious from the photos.Returns also were received for investigation.A total of 179 tubes from batch 9107669 in two 100pack cartons labeled as received 06/12/19 were shipped in a box with air bubbles, bubble wrap and returns for another complaint.No cap, tube or media defects were observed in 179/179 return tubes from visual inspection.For investigation of this complaint, retention and return samples were gram stained by two methods: 1) directly dropping the media on a slide and 2) by cytospin preparation.Gram negative rods were observed in the cytospin preparation slide and no organisms were observed in drop preparation for both return and retention samples.Additional retention tubes were incubated at 33-37°c for three days and then moved to a 55-60°c incubator for an additional seven days.No microbial growth in the form of turbidity in the media was observed after neither the 33-37°c incubation period nor the 55-60°c incubation period.After the 55-60°c incubation, tubes were gram stained, by direct drop, and then plated to non-selective media that was incubated at 33-37°c and 55-60°c for an additional seven days.The gram stains did not show any significant increase in organisms seen compared to non-incubated stains and no microbial growth was observed in any of the plates.Though non-viable organisms were observed in some of the gram stains, this is not an unexpected observation.Bd will continue to trend complaints for contamination or non-viables.This complaint cannot be confirmed.Bd has confirmed the presence of non-viable organisms typically found in culture media constituents.However, because this product does not have a specification for non-viable organisms the complaint cannot be confirmed.Due to the biological nature of the media nonviable organisms can be present.There are statements within the product insert that address the impact of nonviable organisms on the gram staining process in both the precautions and limitations of procedure sections."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.Other sources of dead organisms visible upon gram staining include staining reagents, immersion oil, glass slides and the specimens used for inoculation.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." bd has initiated capa# 1071036 which is in the investigation stage to determine what has caused the increase in non-viable organisms seen within this media.Investigation conclusion: this is an unconfirmed complaint it is out of claims due to there being no specification for non-viables.Root cause description: root cause for the increase in non-viables is undetermined.

Event Description

It was reported that while using bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin for culturing 3 patient samples the lab observed non-viable organisms present in the media.The media was used for 1 blood culture and 2 sterile site cultures.The results were erroneously reported as gram-negative rods for 3 patients.No information was available on how the patient treatment was changed or if treatment was changed.No misdiagnosis or worsening in patient condition was indicated.

• Brand Name: BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN
• Type of Device: MULTIPURPOSE CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 250 schilling circle; cockeysville MD 21030
• MDR Report Key: 8841768
• MDR Text Key: 155853031
• Report Number: 1111096-2019-00107
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 00382902217886
• UDI-Public: 00382902217886
• Combination Product (y/n): N
• PMA/PMN Number: K803023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/27/2019

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: 04/14/2020
• Device Catalogue Number: 221788
• Device Lot Number: 9107669
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 07/30/2019
• Supplement Dates Manufacturer Received: 07/03/2019
• Supplement Dates FDA Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other