MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) PLATE 100PK; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Catalog Number 252028

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

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

Event Date 12/14/2022

Event Type  malfunction  

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 Description

It was reported that bd bbl¿ trypticase¿ soy agar (soybean-casein digest agar) plate 100pk mold was found in the media before use.The following information was provided by the initial reporter: mold was found on the media before usage.

Manufacturer Narrative

The following field was updated: pma/510k info: preamendment h.6 investigation summary: 52028 #2276065 we could confirm this issue as a report due to returned sample.The issue was contamination of fungi.Complaint history was reviewed, and no other complaint has been taken on this lot.At this time.All release testing was satisfactory and no deviations were observed.It includes bioburden testing.A visual inspection was performed on (b)(4) retention samples of this lot.As a result,no defect was observed.The root cause for this could not be determined.We will continue to monitor this lot.

Event Description

It was reported that bd bbl¿ trypticase¿ soy agar (soybean-casein digest agar) plate 100pk mold was found in the media before use.The following information was provided by the initial reporter: mold was found on the media before usage.

• Brand Name: BD BBL¿ TRYPTICASE¿ SOY AGAR (SOYBEAN-CASEIN DIGEST AGAR) PLATE 100PK
• Type of Device: CULTURE MEDIA, NON-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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16035415
• MDR Text Key: 306838828
• Report Number: 1119779-2022-01527
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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: 01/11/2023

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
• Device Operator: Other
• Device Expiration Date: 01/30/2023
• Device Catalogue Number: 252028
• Device Lot Number: 2276065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1