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

Catalog Number 306398

Device Problems Complete Blockage (1094); Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2021

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 had a difficult to move plunger.The following information was provided by the initial reporter: "bd soloshot mini 0.3ml syringe plunger stuck/ blocked half way during vaccine dose injection.".

Event Description

It was reported that syringe soloshot mini 0.3ml 23x1 had a difficult to move plunger.The following information was provided by the initial reporter: "bd soloshot mini 0.3ml syringe plunger stuck/ blocked half way during vaccine dose injection.".

Manufacturer Narrative

Investigation summary: 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, a video was provided for evaluation by our quality engineer team.Through examination of the video, it is observed that the plunger component cannot move down.The video displays the soloshot syringe with the clip activated.Once the clip is activated, the plunger is unable to move, as it is an intentional characteristic of the syringe.When examining the physical samples, one of them was found used with the clip activated.This means the plunger could go up, but it could not go down.Unused samples were also provided; however, no issues were observed with the unused syringes.Bd soloshot mini syringe is an auto-disable two-piece syringe, consisting of two plastic components (plunger and cylinder) and a metal clip.The function of the clip is to avoid reuse of the syringe in order to prevent infection transmission.The reason why the plunger cannot move forward is because the clip has already been activated.The user should ensure that the syringe is totally closed before drawing up medication.If it is preferred that the plunger move more than once, there are other bd syringes available with such abilities.

• Brand Name: SYRINGE SOLOSHOT MINI 0.3ML 23X1
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12525889
• MDR Text Key: 273108233
• Report Number: 3002682307-2021-00513
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• 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: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306398
• Device Lot Number: 2104421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 11/04/2021
• Supplement Dates FDA Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1