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

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: syringe plunger stuck during vaccine administration to client.Plunger stopped half way during injection procedure, not moving even with hard push, it get jammed and get bent.Many such incidences are occurring in the vaccine center.Patient impact: the vaccine recipient/client complains very painful injection.Tthe 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 2104424.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, a used physical sample was returned for evaluation by our quality engineer team.The sample had medication in the fluid path and the clip was already activated.Since the clip was already activated, the plunger may go up, but it cannot go down.Two unused samples were also provided.The two unused samples displayed no signs of defect.The cannula points were microscopically examined and no signs of damage were detected.H3 other text : see h.10.

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: syringe plunger stuck during vaccine administration to client.Plunger stopped half way during injection procedure, not moving even with hard push, it get jammed and get bent.Many such incidences are occurring in the vaccine center.Patient impact: the vaccine recipient/client complains very painful injection.Tthe 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.

• 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 Key: 12471257
• MDR Text Key: 271494691
• Report Number: 3002682307-2021-00486
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• 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 Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306398
• Device Lot Number: 2104424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1