MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ SABOURAUD DEXTROSE CC AGAR SLANTS WITH CHLORAMPHENICOL AND CYCLOHEXIMIDE; CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Model Number	297649
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd bbl¿ sabouraud dextrose cc agar slants with chloramphenicol and cycloheximide bacterial contamination was observed by the laboratory personnel.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: "good morning, (b)(6), we've had bacterial contamination in the dermatophyte culture media.".
Event or Problem Description
It was reported that while using bd bbl¿ sabouraud dextrose cc agar slants with chloramphenicol and cycloheximide bacterial contamination was observed by the laboratory personnel.There was no indication that results were reported out and there was no report of patient impact.
Additional Manufacturer Narrative
H.6.Investigation: material 297649 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 0317156 was satisfactory and no quality notifications were generated during manufacturing and inspection.Qc inspection and testing were satisfactory at time of release.In process checks were performed at the designated intervals.Those checks confirmed that the caps were tightened to the validated specifications per internal procedure.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 no other complaint has been taken on this batch.Retention samples from batch 0317156 (10 tubes) were available for investigation.Each tube (10/10) showed no signs of contamination from visual inspection.For investigation, two uninoculated retention tubes were incubated for seven days.One was placed in the 33 to 37 degree c incubator and one tube was placed in the 20 to 25 degree c incubator.No microbial growth was observed in 2/2 incubated retention tubes.No returns were received to assist with the investigation.Two photos were received to assist with the investigation: the first photo shows a tube and along the slant there does appear to be bacterial like colonies.The second photo shows a closed bd carton box from batch 0317156 carton box number 027.The complaint can be confirmed by the photos provided.Based on the defect rate, no actions are planned at this time.Bd will continue to trend complaints for contamination.H3 other text : see h.10.

• Brand Name: BD BBL¿ SABOURAUD DEXTROSE CC AGAR SLANTS WITH CHLORAMPHENICOL AND CYCLOHEXIMIDE
• Common Device Name: CULTURE MEDIA, SELECTIVE AND NON-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: 11979515
• Report Number: 1119779-2021-00986
• Device Sequence Number: 11610073
• Product Code: JSJ
• UDI-Device Identifier: 30382902976494
• UDI-Public: 30382902976494
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2021

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
• Operator of Device: Other
• Device Expiration Date: 10/29/2021
• Device Model Number: 297649
• Device Catalogue Number: 297649
• Device Lot Number: 0317156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown