MAUDE Adverse Event Report: REMEL/THERMO FISHER SCIENTIFIC MALT EXTRACT PLATE; CULTURE MEDIA, NON SELECTIVE AND NON DIFFERENTIAL

Catalog Number R01567

Device Problem Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)

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

Event Date 07/10/2017

Event Type  malfunction  

Event Description

Technician opened new box of remel malt extract plates ((b)(4), lot# 169889, exp.08/23/2017) and found one of the plates to contain a fragment of cardboard on/within agar.

• Brand Name: MALT EXTRACT PLATE
• Type of Device: CULTURE MEDIA, NON SELECTIVE AND NON DIFFERENTIAL
• Manufacturer (Section D): REMEL/THERMO FISHER SCIENTIFIC; lenexa KS 66215
• MDR Report Key: 6714029
• MDR Text Key: 80247210
• Report Number: MW5070994
• Device Sequence Number: 1
• Product Code: JSG
• 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: 07/12/2017

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: Health Professional
• Device Expiration Date: 08/23/2017
• Device Catalogue Number: R01567
• Device Lot Number: 169889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2017
• 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