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

Catalog Number 221742

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

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

Event Date 07/15/2019

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

Media contains non-viables.Gram stains show gram negative rods.3-4 patient results reported in error.Customer does not believe that there were any adverse patient effects.Advised customer that non-viables may be present in liquid media.

Manufacturer Narrative

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 9087634 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 have been taken on this batch for appearance but are also unconfirmed.Retention samples from batch 9087634 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.Returns were received for investigation.Forty-seven tubes from batch 9087634 in a 100pack carton (#300) were shipped in a box with cardboard and plastic padding.No cap, tube or media defects were observed in 47/47 returned 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 the retention samples tested.Gram variable rods were observed in both the cytospin and direct drop preparations of the return 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.Bd has initiated capa# (b)(4) which is in the investigation stage to determine what has caused the increase in non-viable organisms seen within this media.If you have any further questions please contact technical services.

Event Description

Media contains non-viables.Gram stains show gram negative rods.3-4 patient results reported in error.Customer does not believe that there were any adverse patient effects.Advised customer that non-viables may be present in liquid media.

• 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: 8883701
• MDR Text Key: 155702193
• Report Number: 1111096-2019-00111
• Device Sequence Number: 1
• Product Code: JSG
• 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: 11/12/2019

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: 03/20/2020
• Device Catalogue Number: 221742
• Device Lot Number: 9087634
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/12/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other