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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL CHROMAGAR ORIENTATION AND BBL TRYPTICASE SOY AGAR PLATE; CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL
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BECTON, DICKINSON & CO. (SPARKS) BD BBL CHROMAGAR ORIENTATION AND BBL TRYPTICASE SOY AGAR PLATE; CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL Back to Search Results
Model Number 222239
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/06/2021
Event Type  malfunction  
Manufacturer Narrative
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 while using 40 bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (tsa ii)-i plate¿ contamination was observed by the laboratory personnel.Additionally, a physical defect was observed in by the laboratory personnel in 70 plates.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "it was reported that customer reports receipt of item 222239 lot 1106169 - plate bi chromagar orient/tsa ii sb with cracked plates and contamination.".
 
Event Description
It was reported that while using 40 bd bbl¿ chromagar¿ orientation and bbl¿ trypticase¿ soy agar w/5% sheep blood (tsa ii)-i plate¿ contamination was observed by the laboratory personnel.Additionally, a physical defect was observed in by the laboratory personnel in 70 plates.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "it was reported that customer reports receipt of item 222239 lot 1106169 - plate bi chromagar orient/tsa ii sb with cracked plates and contamination.".
 
Manufacturer Narrative
The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 2021-05-10 investigation summary: during manufacturing of material 222239, media is formulated and sent through a high temperature short time sterilizer to remove bioburden.The petri dishes are subjected to uv radiation to decrease bioburden.The petri dishes are filled in a positive pressure hepa filtered environment.The filled plates are cooled and immediately wrapped into sleeves to decrease the introduction of microbes.Sleeves are then packaged into cartons and then transferred to a refrigerated truck (2 to 8 degrees c) for shipment to the distributor.Bd distributors are provided with the storage guidelines for the shipping and handling of bd media of 2 to 8 degrees c in a dark place.The batch history record for batch 1106169 was satisfactory at time of release and no quality notifications were generated during manufacturing and inspection.The release testing that is performed on this product does include physical attribute and bioburden testing.Sample plates are incubated at 25 degrees c and at 35 degrees c for approximately 72 hours.They are tested for physical attributes prior to release to ensure that they conform to typical levels.All physical attribute and bioburden testing performed on this batch was satisfactory per our internal procedures.The plates in question are not sterile.They are tested for bioburden prior to release to ensure that they conform to typical levels.However, this does not ensure that the end-user will not receive a contaminated plate.The complaint history was reviewed, and three other complaints have been taken on this batch for contamination including two others from this customer for different shipments ((b)(6)).Retention samples from batch 1106169 were not available for inspection.Nine photos were received for investigation.One photo shows 11 unopened sleeves from batch 1106169.Four photos each shows a close up of the side of a sleeve with cracks in the sides of the lids visible.The other four photos each shows the side of a sleeve from batch 1106169 with a darkened agar bed highlighted in the medium.The darkening of the medis is presumably from growth even though colonies are not directly observed.Returns also were received for investigation.Forty plates from batch 1106169 were returned as ten loose plates held together with a rubber band in a ziplock bag and three unopened sleeves shipped in a box.A carton label from batch 1106169 (carton number 0137) also was included.Plates were inspected and surface and subsurface bacterial growth were observed in 4/40 plates returned and 25/40 plates had cracked lids (time stamps 0942, 0945, 0955, 0958, 0959) one affected plate was submitted to the id lab and pseudomonas fluoresens and serratia liquefaciens were identified.Bd ships product in temperature controlled trucks to distribution centers.Distribution centers are provided with shipping and storage guidelines.Dropping of the plates and vibrations during shipping can cause broken or cracked plates.Bd will continue to trend complaints for defects.This complaint can be confirmed for broken plates and contamination.A capa (corrective and preventative actions) 3076308 has been initiated to determine the root cause and corrective actions of the contamination.
 
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Brand Name
BD BBL CHROMAGAR ORIENTATION AND BBL TRYPTICASE SOY AGAR PLATE
Type of Device
CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL
Manufacturer (Section D)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
MDR Report Key11917020
MDR Text Key273158998
Report Number1119779-2021-00938
Device Sequence Number1
Product Code JSH
UDI-Device Identifier10382902222399
UDI-Public10382902222399
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 08/31/2021
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 Date07/12/2021
Device Model Number222239
Device Catalogue Number222239
Device Lot Number1106169
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2021
Initial Date Manufacturer Received 05/06/2021
Initial Date FDA Received06/01/2021
Supplement Dates Manufacturer Received08/31/2021
Supplement Dates FDA Received09/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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