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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BERPU MEDICAL TECHNOLOGY CO., LTD EASYTOUCH; INSULIN SYRINGES
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BERPU MEDICAL TECHNOLOGY CO., LTD EASYTOUCH; INSULIN SYRINGES Back to Search Results
Catalog Number 831165
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/24/2023
Event Type  malfunction  
Event Description
End user reports that syringes lot 59271 are difficult to inject and draw his novolin n insulin.End user does not depressurize the insulin vial prior to use, user was educated on how to depressurize the insulin vial.
 
Manufacturer Narrative
Initial trend analysis for lot 59271 was conducted, no malfunctions were found.(b)(4).Further investigation will be conducted to determine the root cause of complaint.
 
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Brand Name
EASYTOUCH
Type of Device
INSULIN SYRINGES
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 Key17627957
MDR Text Key322041864
Report Number3005798905-2023-03134
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 Replace
Type of Report Initial
Report Date 08/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number831165
Device Lot Number59271
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/24/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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