MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL TRYPTICASE SOY AGAR SETTLING PLATES

Catalog Number 222205

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2021

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.(b)(4).

Event Description

It was reported that while using bd bbl¿ trypticase¿ soy agar settling plates atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.

Event Description

It was reported that while using bd bbl¿ trypticase¿ soy agar settling plates atypical growth was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.

Manufacturer Narrative

Investigation summary: material 222205 is manufactured by rehydrating the dehydrated culture media (dcm) with usp purified water.The media is then processed through a high temperature short time sterilizer to remove bioburden and is aseptically dispensed directly into petri dishes.The petri dishes are then sealed into clean sleeves and boxed.Personnel working in the filling area are required to wear full body jumpsuits, hoods, boots, masks and gloves.The filled plates are cooled and immediately wrapped to decrease the introduction of microbes.Dispensing and sleeving are completed within an iso certified environment.Sleeves are packed into cartons and then transferred to a refrigerated truck (2 to 8 degrees c) for shipment to the irradiator, product is then shipped to our customers and distributors via refrigerated truck.Bd distributors are provided with the storage guidelines for the shipping and handling of bd media 2 to 8 degrees c in a dark place.The batch history record review for batch 0268628 was satisfactory per internal procedures.The release testing that is performed on this product does include physical attribute testing.Sample plates are tested for physical attributes prior to release to ensure they conform to typical levels.All physical attribute testing performed on this batch was satisfactory per our internal procedures.Also, all batches are tested prior to release and results reported on the certificate of analysis which can be obtained at www.Bd.Com/regdocs.Routine stability studies are performed annually per internal procedures for biological performance to ensure satisfactory performance throughout shelf life with the organisms that are reported on the certificate of analysis (coa) of each product.Stability data for this product is on file.All performance testing on this batch was satisfactory at the time of release.The complaint history was reviewed, and two other complaints have been taken on this batch for agar defects but no other complaints have been taken for performance.Retention samples from batch 0268628 were available for investigation.Two unopened sleeves (20 plates) were inspected, and no defects were observed in the layers of 2/2 retention sleeves.Plates were inspected and no split agar or other agar defects were observed in 20/20 retention plates (time stamps 0808, 0809, 0814 and 0817).For investigation of this complaint, retention plates were tested per the standard performance protocol for material 222205 (balt3124 ver 02b) as described in the coa.All organisms tested had growth as expected on retention plates from batch 0268628.All organisms had heavy growth on non-selective controls and percent recovery on the retention plates as compared to the non-selective controls was satisfactory (within 50-200%) for all organisms.It is noted that an esbl-susceptible e.Coli was used by the customer as negative control, but the performance failure description was for poor recovery of organisms.The performance protocol for this product does not test for inhibition and all organisms tested had satisfactory recovery during investigation testing.Also, to test for dried or split media, the remaining retention plates were incubated at 33 to 37 degrees c and 0/8 plates had split agar or any signs of died out media at 5 days incubation.One photo was received in lieu of returns for investigation.The photo shows a close up of the surface of an agar plate with a split near the edge of the agar bed.There is heavy and varied growth on the plate and no plate print or product label is visible for batch verification.Without batch verification, the photo alone cannot confirm the complaint.Testing of retention samples did not find performance defects or dried media, this complaint cannot be confirmed.

• Brand Name: BD BBL TRYPTICASE SOY AGAR SETTLING PLATES
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11368697
• MDR Text Key: 243814139
• Report Number: 1119779-2021-00370
• Device Sequence Number: 1
• Product Code: JSH
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/10/2021
• Device Catalogue Number: 222205
• Device Lot Number: 0268628
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1