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

Catalog 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	08/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd bbl¿ sabouraud dextrose agar slants with chloramphenicol that there was overgrowth.The following information was provided by the initial reporter: sabouraud tubes for dermatophyte-type fungi grown, quite frequently show bacterial overgrowth.Sabouraud dextrose chloramphenicol tubes for the detection of the growth of dermatophyte-type fungi, quite frequently present bacterial overgrowth a few days after being incubated, so the isolated culture of the fungi is done more difficult and delays the issuance of results.
Additional Manufacturer Narrative
H.6.Investigation summary: the batch history record for batch 3046568 was satisfactory and no quality notifications were generated during manufacturing and inspection.Formulation, filling and autoclaving processes were within specifications.Qc inspection and testing were satisfactory at time of review.The complaint history was reviewed, and no other complaints have been taken on batch 3046568.Retention samples from batch 3046568 (10 tubes) were available for inspection.For this investigation, retention tubes were tested with e.Coli atcc 25922 per the standard performance protocol as described in the certificate of analysis.A non-selective control (sab dex media) was inoculated as a positive growth control and an uninoculated retention tube from batch 3046568 was inoculated as a negative control.No growth of atcc 25922 was seen at 7 days incubation in the retention tube from batch 3046568 as expected.Heavy growth of atcc 25922 was seen in the non-selective control at 7 days incubation and no growth was observed in the uninoculated control from batch 3046568 at 7 days incubation.Three photos were received for investigation.Two photos each feature a tube label from batch 3046568 for batch verification.The other photo features a media slant with growth.Observations about performance cannot be made from a photo.No return samples were received for investigation.Retention sample testing showed no performance defects in batch 3046568.This complaint cannot be confirmed.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 that there was overgrowth.The following information was provided by the initial reporter: sabouraud tubes for dermatophyte-type fungi grown, quite frequently show bacterial overgrowth.Sabouraud dextrose chloramphenicol tubes for the detection of the growth of dermatophyte-type fungi, quite frequently present bacterial overgrowth a few days after being incubated, so the isolated culture of the fungi is done more difficult and delays the issuance of results.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17778263
• Report Number: 1119779-2023-01017
• Device Sequence Number: 6877053
• 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): 03/25/2024

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: 02/16/2024
• Device Catalogue Number: 221825
• Device Lot Number: 3046568
• 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: 08/28/2023
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2023
• 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