MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR (100 SHELF PACK); CULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL

Model Number 215081

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

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

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1126777, medical device expiration date: 2021-08-30, device manufacture date: 2021-05-06.Medical device lot #: 1134633, medical device expiration date: 2021-09-10, device manufacture date: 2021-05-14.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 2 bd bbl¿ chromagar¿ orientation agar (100 shelf pack) atypical growth was observed by the laboratory personnel.A vitek test was used to confirm the results as false positives.The customer stated results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: "it was reported that the chromagar turned pink but the organism turned out to be citrobacter, and not ecoli.".

Event Description

It was reported that while using 2 bd bbl¿ chromagar¿ orientation agar (100 shelf pack) atypical growth was observed by the laboratory personnel.A vitek test was used to confirm the results as false positives.The customer stated results were not reported out so there was no report of patient impact.The following information was provided by the initial reporter: "it was reported that the chromagar turned pink but the organism turned out to be citorbacter, and not ecoli.".

Manufacturer Narrative

H.6.Investigation: during manufacturing of material 215081, 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 records for batches 1126777 and 1134633 were satisfactory and no quality notifications were generated during manufacturing and inspection.All batches are tested prior to release and results reported on the certificate of analysis which can be obtained at www.Bd.Com/regdocs.Chromagar orientation medium is stability tested biennially for biological performance to ensure satisfactory performance throughout shelf life with the organisms that are reported on the certificate of analysis.All performance testing on this batch was satisfactory at the time of release.The complaint history was reviewed, and no other complaints have been taken on batches 1126777 and 1134633.Retention samples from batches 1126777 and 1134633 were not available for inspection.Three photos were received for investigation.One photo shows the agar surface of two opened plates: one is an opened bi-plate with growth on both media and the other plate is from batch 1126777 (time stamp 1027) with pink-colored colonies.Another photo shows the agar surface of two opened plates with inoculated media: one plate appears to be blood containing media and the other is from batch 1134633 (time stamp 0951) with pink colonies.The last photo shows a screen display of an identification result for citrobacter freundii.Two reports for the identification of citrobacter freundii also were received.No return samples were received for investigation.Conclusions concerning performance cannot be made from photos alone.This complaint cannot be confirmed.Bd will continue to trend complaints for performances.Please note from the intended use statement in the package insert, ¿bbl chromagar orientation medium allows for the differentiation and identification of escherichia coli and enterococcus without confirmatory testing,¿ due to the relatively high sensitivity and specificity of their chromogenic reactions.In the clinical performance section, sensitivity of the medium for detection of e.Coli is 96.9%, while specificity is 98.9%, therefore while there is a very small risk of erroneous results (in this case, a false positive), it will likely not be detected by the user.Treatment of uncomplicated utis is usually empiric therapy.The choice of antibiotic for what is thought to be an uncomplicated uti due to e.Coli would also be effective if the uti was due to c.Freundii.For more complicated cases and patients with risk factors, antimicrobial susceptibility testing (ast) may be performed to determine appropriate therapy.Proper identification of the isolate from urine specimens aids in performing ast tests.In the event that c.Freundii isolates exhibit the same chromogenic reaction expected for e.Coli (dark rose to pink colony growth), the error may be caught upon subsequent id/ast testing.Even if an ast-only panel is set up with the presumptive id of e.Coli, the inherent sir drug susceptibility results is expected to be effective for c.Freundii.Although the antibiogram might appear as if it were a particularly resistant ¿e.Coli¿, there would be no impact to patient treatment decisions based upon the erroneous id from chromagar orientation isolation.Therefore, a misidentification of c.Freundii as e.Coli is unlikely to cause or contribute to a death or serious injury.

• Brand Name: BD BBL¿ CHROMAGAR¿ ORIENTATION AGAR (100 SHELF PACK)
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12253207
• MDR Text Key: 264319535
• Report Number: 1119779-2021-01251
• Device Sequence Number: 1
• Product Code: JSH
• UDI-Device Identifier: 10382902150814
• UDI-Public: 10382902150814
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 215081
• Device Catalogue Number: 215081
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1