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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COMPANION MEDICAL INC INPEN MMT-105NNGYNA NOVO NORDISK GRAY SYRINGE, PISTON

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COMPANION MEDICAL INC INPEN MMT-105NNGYNA NOVO NORDISK GRAY SYRINGE, PISTON Back to Search Results
Model Number MMT-105NNGYNA
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 03/08/2022
Event Type  malfunction  
Manufacturer Narrative
Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge.
 
Event Description
Information received by medtronic indicated that the inpen was no longer working due to the plunger not functioning properly. No harm requiring medical intervention was reported. Troubleshooting was not performed, the customer will continue the use of device.
 
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Brand NameINPEN MMT-105NNGYNA NOVO NORDISK GRAY
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
COMPANION MEDICAL INC
1223 world trade drive, 100
san diego CA 92128
Manufacturer (Section G)
COMPANION MEDICAL INC
1223 world trade drive, 100
san diego CA 92128
Manufacturer Contact
tricha miles
1223 world trade drive, 100
san diego, CA 92128
7635140379
MDR Report Key13719514
MDR Text Key289605495
Report Number3012822846-2022-00219
Device Sequence Number1
Product Code FMF
UDI-Device Identifier000010862088000351
UDI-Public(01)000010862088000351(17)230824
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial
Report Date 03/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-105NNGYNA
Device Catalogue NumberMMT-105NNGYNA
Device Lot NumberB0540
Was Device Available for Evaluation? No
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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