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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: YPSOMED AG KROGER PEN NEEDLES WITH CLICKFINE TECHNOLOGY; NEEDLE, HYPODERMIC, SINGLE LUMEN
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YPSOMED AG KROGER PEN NEEDLES WITH CLICKFINE TECHNOLOGY; NEEDLE, HYPODERMIC, SINGLE LUMEN Back to Search Results
Model Number 181140
Device Problem Use of Device Problem (1670)
Patient Problem Blood Loss (2597)
Event Date 02/25/2019
Event Type  malfunction  
Event Description
Generic pen needle (kroger / perrigo, made by ypsomed) does not fasten securely to lilly insulin pen, when injecting insulin into daughter, insulin and a slight amount of blood occurred.There was no problem with prior provided bd and novo pen needles, they fasten securely.Lilly, the pen provider has not tested the kroger / perrigo / ypsomed needles, and will tell you they¿ve only tested with bd and novo.Ypsomed when contacted, only quotes they¿ve tested to iso 11608-2, which means nothing as near as i can tell.
 
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Brand Name
KROGER PEN NEEDLES WITH CLICKFINE TECHNOLOGY
Type of Device
NEEDLE, HYPODERMIC, SINGLE LUMEN
Manufacturer (Section D)
YPSOMED AG
MDR Report Key8381726
MDR Text Key137591986
Report NumberMW5084518
Device Sequence Number1
Product Code FMI
UDI-Device Identifier00011110338235
UDI-Public011110338235
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 02/27/2019
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 Date05/30/2023
Device Model Number181140
Device Catalogue NumberN/A
Device Lot Number181140-01
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/28/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
ANTI-REFLUX MEDICATION; MAINTENANCE ANTIBIOTIC TO PREVENT UTI REOCCURENCE; MANY SEIZURE MEDICATIONS; OTC MEDS: MULTIVITAMIN; PULSE OXIMETER; RX MEDS: BASAGLAR PEN; SUCTION MACHINE
Patient Outcome(s) Other;
Patient Age34 YR
Patient Weight29
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