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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 Problem Failure to Deliver (2338)
Patient Problem Pain (1994)
Event Date 08/17/2021
Event Type  malfunction  
Manufacturer Narrative
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 soloshot mini 0.3ml 23x1 plunger was difficult to move.The following information was provided by the initial reporter: defected needle tip, double tipped needle, defected needle bevel.Syringe plunger stuck, jammed during vaccine injection.The plunger stuck and stopped moving forward during vaccine administration, so hcp needs to remove needle from client body and noticed that the needle is defected, it has double tip needle points.Hcp re-administer vaccine injection to client with new syringe and with new calculated vaccine dose.There are many such incidences of plunger stuck/lock occurring in the vaccine center.Patient impact: the vaccine recipient/client complains very painful injection.The syringe plunger stuck half way during vaccine dose administration in recipient body.Hcp needs to terminate vaccine injection procedure.Hcp re-administer vaccine to client.Client received two injection shots.
 
Event Description
It was reported that syringe soloshot mini 0.3ml 23x1 plunger was difficult to move.The following information was provided by the initial reporter: defected needle tip, double tipped needle, defected needle bevel.Syringe plunger stuck, jammed during vaccine injection.The plunger stuck and stopped moving forward during vaccine administration, so hcp needs to remove needle from client body and noticed that the needle is defected, it has double tip needle points.Hcp re-administer vaccine injection to client with new syringe and with new calculated vaccine dose.There are many such incidences of plunger stuck/lock occurring in the vaccine center.Patient impact: the vaccine recipient/client complains very painful injection.The syringe plunger stuck half way during vaccine dose administration in recipient body.Hcp needs to terminate vaccine injection procedure.Hcp re-administer vaccine to client.Client received two injection shots.
 
Manufacturer Narrative
H.6.Investigation: a device history record review was completed for provided lot number 2104421.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, the affected sample was returned for evaluation by our quality engineer team.No issues with plunger movement difficulty were identified with the used sample.Three unused syringes were also returned for evaluation and no issues were detected upon investigation.In regards to the issue of plunger movement difficulty, we would like to inform you that the bd soloshot mini syringes are single use devices.The auto-disable two-piece syringe consists of two plastic parts and a metallic clip.The function of this clip is to avoid reuse of the syringe to prevent infection transmission.Once the clip is activated, the syringe plunger will not depress.The syringe should be totally closed before drawing up medication.
 
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Brand Name
SYRINGE SOLOSHOT MINI 0.3ML 23X1
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP  22520
MDR Report Key12469381
MDR Text Key271356059
Report Number3002682307-2021-00480
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 10/01/2021
1 Device was Involved in the Event
1 Patient was 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 Number2104421
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2021
Date Manufacturer Received10/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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