MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD RODAC SNAP LID TRYPTICASE SOY AGAR (TSA) W LECITHIN & POLYSORBATE 80

Catalog Number 215285

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported while using bd rodac¿ snap lid trypticase¿ soy agar (tsa) w lecithin & polysorbate 80 the label on plates were missing first 2 digits of lot number.This occurred with 6 plates, the patient impact was not reported.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 1119779-2021-00239 was sent in error.This product is not a medical device, therefore, it is not considered to be a reportable.

Event Description

It was reported while using bd rodac¿ snap lid trypticase¿ soy agar (tsa) w lecithin & polysorbate 80 the label on plates were missing first 2 digits of lot number.This occurred with 6 plates, the patient impact was not reported.

• Brand Name: BD RODAC SNAP LID TRYPTICASE SOY AGAR (TSA) W LECITHIN & POLYSORBATE 80
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11275936
• MDR Text Key: 231210462
• Report Number: 1119779-2021-00239
• Device Sequence Number: 1
• Product Code: JSG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

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
• Device Operator: Other
• Device Expiration Date: 02/08/2021
• Device Catalogue Number: 215285
• Device Lot Number: 0254281
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2021
• Initial Date FDA Received: 02/03/2021
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1