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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 Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/09/2021
Event Type  malfunction  
Manufacturer Narrative
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 1ml ls sp120 experienced foreign matter in the fluid path, and leakage past the plunger. The following information was provided by the initial reporter: a sticky and transparent liquid leaked out of the back of the plunger of the syringe, it was probably silicone. However, it has only occurred with one syringe.
 
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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 Key12595171
MDR Text Key277417993
Report Number3003152976-2021-00667
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 11/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number303172
Device Lot Number2101042
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/04/2021
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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