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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BERPU MEDICAL TECHNOLOGY CO., LTD EASYTOUCH; INSULIN SYRINGE
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BERPU MEDICAL TECHNOLOGY CO., LTD EASYTOUCH; INSULIN SYRINGE Back to Search Results
Device Problems Product Quality Problem (1506); Material Too Rigid or Stiff (1544); Dull, Blunt (2407); Material Integrity Problem (2978)
Patient Problem Pain (1994)
Event Date 11/01/2023
Event Type  malfunction  
Event Description
End user reports that the cannulas on syringe lots 59693 expiration date 04/09/20207 and 58196a expiration date 01/18/2027 have burrs and the needle is catching the skin causing them pain.User also reports that the plunger is easily removed from the barrel.
 
Manufacturer Narrative
Initial trend analysis for lots 59693 and 58196a was conducted, no malfunctions were found.This is the only complaint for lots 59693 and 58196a.Further investigation will be conducted to determine the root cause of complaint.
 
Event Description
End user reports that the cannulas on syringe lots 59693 expiration date 04/09/20207 and 58196a expiration date 01/18/2027 have burrs and the needle is catching the skin causing them pain.User also reports that the plunger is easily removed from the barrel.
 
Manufacturer Narrative
Cmo inspected retained lot 58196a, no abnormalities were found during testing.
 
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Brand Name
EASYTOUCH
Type of Device
INSULIN SYRINGE
Manufacturer (Section D)
BERPU MEDICAL TECHNOLOGY CO., LTD
no.14 xingji road
yongxing street
wenzhou city, longwan 32500 0
CH  325000
Manufacturer (Section G)
BERPU MEDICAL TECHNOLOGY CO., LTD
no.14 xingji road
yongxing street
wenzhou city, longwan 32500 0
CH   325000
Manufacturer Contact
troy smith
8695 seward road
fairfield, OH 45011
MDR Report Key18178582
MDR Text Key328633500
Report Number3005798905-2023-03147
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102178
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Notification
Type of Report Initial,Followup
Report Date 11/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received11/01/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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