MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD PLATE SABOURAUD DEXTROSE AGAR CG; CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

Catalog Number 251359

Device Problem Contamination (1120)

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

Event Date 04/27/2022

Event Type  malfunction  

Manufacturer Narrative

There is no 510(k) for this device as it is manufactured outside the us and not sold in the us but is considered to be substantially similar to the legally u.S.Marketed device bd bbl¿ sabouraud dextrose agar slants catalog number 221012 with 510k number exempt.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1334477.Medical device expiration date: 2022-03-29.Device manufacture date: 2021-11-30.Medical device lot #: 2024413.Medical device expiration date: 2022-05-23.Device manufacture date: 2022-01-24.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that prior to use with bd plate sabouraud dextrose agar cg mold was discovered.The following information was provided by the initial reporter: this is a report about contamination of the media.The customer found mold in the unused media.Since the customer has experienced the same issue before, the customer requests that the cause and countermeasures to be included in the report.If there is consideration regarding storage of the media at a facility, it is also requested to be included.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 26-may-2022.H.6.Investigation: we confirmed the issue as a report from a returned sample.The issue was contamination.No issue in device history record review.No issue in retention of lot 2024413.Lot 1334477 was already expired; no retention review available for this lot.No trend.We will continue to monitor this issue.

Event Description

It was reported that prior to use with bd plate sabouraud dextrose agar cg mold was discovered.The following information was provided by the initial reporter: this is a report about contamination of the media.The customer found mold in the unused media.Since the customer has experienced the same issue before, the customer requests that the cause and countermeasures to be included in the report.If there is consideration regarding storage of the media at a facility, it is also requested to be included.

• Brand Name: BD PLATE SABOURAUD DEXTROSE AGAR CG
• Type of Device: 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: roxanne tidwell ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14518616
• MDR Text Key: 295973160
• Report Number: 1119779-2022-00770
• Device Sequence Number: 1
• Product Code: JSI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 251359
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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