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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE SOLOSHOT MINI 0.3ML 23X1

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BECTON DICKINSON, S.A. SYRINGE SOLOSHOT MINI 0.3ML 23X1 Back to Search Results
Catalog Number 306398
Device Problems Failure to Deliver (2338); Device Contamination with Chemical or Other Material (2944); Material Twisted/Bent (2981)
Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/18/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that syringe soloshot mini 0. 3ml 23x1 plunger was difficult to move and bent during use. There was also foreign matter. The following information was provided by the initial reporter: material inside the package (looks like metal). Syringe plunger bended during pushing vaccine inside the arm. Plunger stuck in the middle while giving the vaccine. Needle take's some of the rubber during inserting the needle in the vaccine vial. Patient impact: wasted syringes. Wasted vaccine doses. Patient complaint of pain.
 
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Brand NameSYRINGE SOLOSHOT MINI 0.3ML 23X1
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 Key12471175
MDR Text Key273868655
Report Number3002682307-2021-00483
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeSA
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 Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number306398
Device Lot NumberUNKNOWN
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 Received08/18/2021
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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