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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BERPU MEDICAL TECHNOLOGY CO., LTD EASYTOUCH; SYRINGE
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BERPU MEDICAL TECHNOLOGY CO., LTD EASYTOUCH; SYRINGE Back to Search Results
Catalog Number 830355
Device Problems Device Damaged Prior to Use (2284); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/11/2023
Event Type  malfunction  
Manufacturer Narrative
Initial trend analysis for lot 64521 was conducted, no malfunctions were found.This is the only complaint for lot 64521.Further investigation will be conducted to determine the root cause of complaint.
 
Event Description
End user reports finding 2 syringes in two different boxes of 30g.3cc 1/2" size syringes were different than the others in the box.The two syringes had a longer needle and a longer barrel size.Both syringes were discarded and unused and only one syringe lot was recorded by the user.
 
Manufacturer Narrative
No device was returned for testing.Retained lot 64521 was investigated and no abnormalities were detected.
 
Event Description
End user reports finding 2 syringes in two different boxes of 30g.3cc 1/2" size syringes were different than the others in the box.The two syringes had a longer needle and a longer barrel size.Both syringes were discarded and unused and only one syringe lot was recorded by the user.
 
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Brand Name
EASYTOUCH
Type of Device
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 Key18357520
MDR Text Key330935193
Report Number3005798905-2023-03154
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,Followup
Report Date 12/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number830355
Device Lot Number64521
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/11/2023
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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