MAUDE Adverse Event Report: BIOMERIEUX INC. IRRADIATED TRYPTIC SOY AGAR WITH LECITHIN AND POLYSORBATE 80 BIOMERIEUX MEDIA TS; CULTURE MEDIA NON-SELECTIVE AND NON-DIFFERENTIAL

Catalog Number M1060-IR

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/14/2019

Event Type  malfunction  

Event Description

Biomerieux plate (m1060-ir, tsa w/l&p80, lot# 1006837780, exp.04/14/2019) had no inscription printed on it.

• Brand Name: IRRADIATED TRYPTIC SOY AGAR WITH LECITHIN AND POLYSORBATE 80 BIOMERIEUX MEDIA TS
• Type of Device: CULTURE MEDIA NON-SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BIOMERIEUX INC.
• MDR Report Key: 8261148
• MDR Text Key: 133829660
• Report Number: MW5083241
• Device Sequence Number: 1
• Product Code: JSJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2019
• Device Catalogue Number: M1060-IR
• Device Lot Number: 1006837780
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1