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

Model Number	221825
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	06/03/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that while using bd bbl¿ sabouraud dextrose agar slants with chloramphenicol atypical growth was observed by the laboratory personnel.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: " unexpected growth of bacteria.Does not inhibit growth ".
Additional Manufacturer Narrative
H.6.Investigation: material 221825 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 1035051 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling, and autoclaving process were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other complaint has been taken on this batch.Retention samples from batch 1035051 (10 tubes) were available for investigation.Each tube (10/10) showed no signs of defect or contamination from visual inspection.For investigation, performance testing was performed on inhibiting the growth of bacteria.All performance testing was satisfactory the media does inhibit the growth of bacteria.The negative control remained negative for seven days of incubation.Additional testing was also performed on one uninoculated tube.One uninoculated tube was incubated at 20-25 degrees celsius for a seven-day incubation period.At the end of seven days there was no microbial growth observed.One photo was received to assist with the investigation.The photo shows a partial carton from batch 1035051 carton number 007.No returns were received to assist with the investigation.The complaint cannot be confirmed by the photo provided or from the testing of the retention sample.Bd will continue to trend complaints for performance.
Event or Problem Description
It was reported that while using bd bbl¿ sabouraud dextrose agar slants with chloramphenicol atypical growth was observed by the laboratory personnel.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: " unexpected growth of bacteria.Does not inhibit growth ".

• Brand Name: BD BBL¿ SABOURAUD DEXTROSE AGAR SLANTS WITH CHLORAMPHENICOL
• Common Device Name: CULTURE MEDIA, 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: 12124190
• Report Number: 1119779-2021-01120
• Device Sequence Number: 14335094
• Product Code: JSI
• UDI-Device Identifier: 30382902218259
• UDI-Public: 30382902218259
• 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): 01/27/2022

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: 02/05/2022
• Device Model Number: 221825
• Device Catalogue Number: 221825
• Device Lot Number: 1035051
• 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: 06/08/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2021
• 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