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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: YANGZHOU MEDLINE INDUSTRY CO.LTD. YANGZHOU MEDLINE INDUSTRY CO.LTD.; SAFETY NEEDLE

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YANGZHOU MEDLINE INDUSTRY CO.LTD. YANGZHOU MEDLINE INDUSTRY CO.LTD.; SAFETY NEEDLE Back to Search Results
Catalog Number N-2515
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 09/01/2021
Event Type  malfunction  
Event Description
The customer reported after vaccine is drawn up during the injection the medicine leaked from the needle/syringe.Our main issue is the majority of our patients fall into the 1" needles.In every covid-19 kits we have received there are not enough 1" needles included for the majority of our size patients.No information was received regarding any serious injury as a result of this product malfunction.
 
Manufacturer Narrative
According to the production records, the batch number is (b)(4), specification is 25gx1-1/2'', and product code is n-2515.There are no similar abnormalities in the production and inspection records during the production process; according to the customer's complaint, the raw material inspection shows that the performance of granular and needle meets the requirements; after the re-inspection of reserved samples (same batch) and the confirmation of products in process, the relevant dimensions of the connecting parts meet the requirements.Matching, separation force and tightness performance can meet the requirements of iso80369 standard; according to the above investigation and testing, our product can fully meet the tightness requirements according to the manual requirement, and there will be no leakage.Therefore, the use of our safety needle must be operated in accordance with the manual requirements, so as to avoid the phenomenon described in the customer complaint.
 
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Brand Name
YANGZHOU MEDLINE INDUSTRY CO.LTD.
Type of Device
SAFETY NEEDLE
Manufacturer (Section D)
YANGZHOU MEDLINE INDUSTRY CO.LTD.
no 108,jinshan road
economic development zone
yangzhou, jiangsu 22500 9
CH  225009
Manufacturer (Section G)
WEIWEI CUI
no.108, jinshan road
economic development zone
yangzhou, jiangsu 22500 9
CH   225009
Manufacturer Contact
weiwei cui
no.108, jinshan road
economic development zone
yangzhou, jiangsu 22500-9
CH   225009
MDR Report Key12765537
MDR Text Key281281727
Report Number3010732234-2021-00002
Device Sequence Number1
Product Code MEG
UDI-Device Identifier06970114923950
UDI-Public(01)06970114923950(17)251112(10)SN201114
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 10/22/2021
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 Health Professional
Device Catalogue NumberN-2515
Device Lot NumberSN201114
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/23/2021
Initial Date FDA Received11/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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