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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 1ML LS SP120

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BECTON DICKINSON, S.A. SYRINGE 1ML LS SP120 Back to Search Results
Catalog Number 303172
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2021
Event Type  malfunction  
Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 1903008. Medical device expiration date: 2024-02-29. Device manufacture date: 2019-03-14. Medical device lot #: 1908004. Medical device expiration date: 2024-07-31. Device manufacture date: 2019-08-05. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that syringe 1ml ls sp120 leaked. The following information was provided by the initial reporter: the physician found that the connection site between the injection needle and the syringe was blocked when trying to inject the liquid. Then the liquid is ejected from the connection site between the injection needle and the syringe and cannot be injected into the patient's eye.
 
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Brand NameSYRINGE 1ML LS SP120
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12571608
MDR Text Key274816082
Report Number3003152976-2021-00657
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number303172
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/13/2021
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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