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

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.

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: 1.Material inside the package (looks like metal).2.Syringe plunger bended during pushing vaccine inside the arm.3.Plunger stuck in the middle while giving the vaccine.4.Needle take's some of the rubber during inserting the needle in the vaccine vial.Patient impact: 1.Wasted syringes.2.Wasted vaccine doses.3.Patient complaint of pain.

Manufacturer Narrative

H.6.Investigation: to aid in the investigation of this issue, a video sample was provided for evaluation by our quality engineer team.Through examination of the video, it can be observed that the plunger rod bends easily and that there was plunger movement difficulty.The characteristic of the soloshot mini syringes is that the plunger cannot be depressed once the clip has been activated.It has been determined that the issues of plunger rod bends and plunger movement difficulty resulted from the handling of the product.The bd soloshot mini auto-disable syringes are single-use medical devices.The auto-disable syringe consists of two plastic parts called the plunger and the cylinder and a metallic piece called the clip.The function of this clip is to avoid reuse of the syringe to prevent infection transmission.Once the clip is activated, the plunger cannot be depressed and the plunger will appear stuck if pushed.The user should ensure that the syringe is totally closed before drawing up the medication.Picture samples were returned for evaluation of foreign matter on the product.Through examination of the pictures, our quality engineer team identified two different types of black foreign matter within the blister packages.It is possible that the pictured foreign matter originated from some residue within the packaging machinery used.Regrettably, without the physical sample, further analysis cannot be performed to identify the composition and exact origin of the foreign matter pictured.As a lot number was unknown for this incident, a device history record review could not be completed.H3 other text : see h.10.

• Brand Name: SYRINGE SOLOSHOT MINI 0.3ML 23X1
• Type of Device: SYRINGE
• 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 Key: 12471175
• MDR Text Key: 273868655
• Report Number: 3002682307-2021-00483
• 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: 10/15/2021

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2021
• 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
• Patient Sequence Number: 1