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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REMEL REMEL BILE ESCULIN AZIDE AGAR W/6UG VANC

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REMEL REMEL BILE ESCULIN AZIDE AGAR W/6UG VANC Back to Search Results
Model Number R01186
Device Problem Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 03/15/2021
Event Type  malfunction  
Manufacturer Narrative
Retain samples of the complaint lot were set against a comparison lot. The reported lot, comparison lot, and viability lot plates were set following the inspection plan procedure in duplicate with e. Faecalis atcc 29212 and e. Coli atcc 25922 using a mcf 0. 5 dilution and e. Faecalis atcc 51299 using a 1:100 dilution. A 10^-5 backtiter was set for all viability plates. All the plates were incubated at 33-37c in ambient atmosphere for 24 hours on top of the plate rack (per ip). The complaint was confirmed as complaint lot had good growth with blackening for e. Faecalis atcc 29212. A review of the batch record was also completed. Further review indicated an incorrect raw material was added.
 
Event Description
Qc failed. E. Faecalis atcc 29212 grew very well. No patient impact reported.
 
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Brand NameREMEL
Type of DeviceBILE ESCULIN AZIDE AGAR W/6UG VANC
Manufacturer (Section D)
REMEL
12076 santa fe trail drive
lenexa KS 66215
MDR Report Key11674706
MDR Text Key280547160
Report Number1924669-2021-00002
Device Sequence Number1
Product Code JSO
Combination Product (y/n)N
PMA/PMN Number
K972359
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Remedial Action Recall
Type of Report Initial
Report Date 04/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/27/2021
Device Model NumberR01186
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2021
Is This a Reprocessed and Reused Single-Use Device? No

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