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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 2ML LS 23X1-1/4 DN EMERALD

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BECTON DICKINSON, S.A. SYRINGE 2ML LS 23X1-1/4 DN EMERALD Back to Search Results
Catalog Number 307730
Device Problems Leak/Splash (1354); Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2021
Event Type  malfunction  
Manufacturer Narrative
There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 1607240. Medical device expiration date: 2021-06-30. Device manufacture date: 2016-07-21. Medical device lot #: 1609126. Medical device expiration date: 2021-08-31. Device manufacture date: 2016-08-31. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the syringe 2ml ls 23x1-1/4 dn emerald experienced difficult plunger movement. The following information was provided by the initial reporter: the product was very poor, such that when the filled medicine is pushed (injecting) it needs a lot of energy to push, ie it stuck upon pushing, it's not softly pushed as normal syringes.
 
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Brand NameSYRINGE 2ML LS 23X1-1/4 DN EMERALD
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP 22520
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP 22520
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12555340
MDR Text Key274347237
Report Number3002682307-2021-00527
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeTZ
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number307730
Device Lot NumberSEE H10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/02/2021
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

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