MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) PLATE THAYER-MARTIN SELECTIVE AGAR

Catalog Number 251184

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2021

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 plate thayer-martin selective agar there was a failure to inhibit proteus.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted mfr report# was sent in error.This material # is an luo (laboratory use only) and does not meet the criteria of a medical device as stated in 21 cfr 803.Therefore, this complaint is not mdr reportable.

Event Description

It was reported while using plate thayer-martin selective agar there was a failure to inhibit proteus.

• Brand Name: PLATE THAYER-MARTIN SELECTIVE AGAR
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• MDR Report Key: 11244773
• MDR Text Key: 230246949
• Report Number: 1119779-2021-00157
• Device Sequence Number: 1
• Product Code: JTY
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

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: 01/18/2021
• Device Catalogue Number: 251184
• Device Lot Number: 0268186
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: 07/12/2021
• Supplement Dates FDA Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1