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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 830155
Device Problems Loss of or Failure to Bond (1068); Break (1069); Mechanical Problem (1384); Product Quality Problem (1506); Detachment of Device or Device Component (2907); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2024
Event Type  malfunction  
Event Description
End user contacted a direct customer regarding syringe item 830155 lot 58154.User reported that the cannula broke off prior to use and the syringes that were not defective prior to use are breaking off where the cannula meets the hub.No injury reported.
 
Manufacturer Narrative
Initial trend analysis for lot 58154 was conducted, no malfunctions were found.This is the only complaint for lot 58154.Further investigation will be conducted to determine the root cause of complaint.
 
Event Description
End user contacted a direct customer regarding syringe item 830155 lot 58154.User reported that the cannula broke off prior to use and the syringes that were not defective prior to use are breaking off where the cannula meets the hub.No injury reported.
 
Manufacturer Narrative
The cmo checked manufacturing process and evaluated retained lot samples; no abnormalities found.
 
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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 Key18695248
MDR Text Key335251468
Report Number3005798905-2024-03165
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 Followup
Report Date 02/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number830155
Device Lot Number58154
Was Device Available for Evaluation? No
Date Manufacturer Received02/08/2024
Was Device Evaluated by Manufacturer? No
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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