MAUDE Adverse Event Report: FUTURE DIAGNOSTICS, LLC. CARE TOUCH 1ML SYRINGE; SYRINGE, PISTON

Device Problems Break (1069); Fail-Safe Did Not Operate (4046)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 04/01/2021

Event Type  Injury  

Event Description

[pfizer vaccine] treatment under emergency use authorization(eua): emergency use authorization (eua) of the pfizer-biontech covid-19 vaccine to prevent coronavirus disease 2019 (covid-19) there have been two problems with the caretouch syringe that had lead to an adverse "dirty needle stick" of a vaccinator requiring the vaccinator to go to the er for (b)(6) testing and initiation of post-exposure prophylaxis (b)(6) medications.First incident ((b)(6) 2021): this event occurred as the vaccinator went to activate the safety device of the 23g 1 and 1/2" dps safety needle.The vaccinator used a table to close the safety device; however, as they applied pressure the neck of the caretouch 1ml syringe (connecting it to the needle) broke.The needle then flipped back puncturing the hand of the vaccinator.Second incident ((b)(6) 2021): this event occurred as the vaccinator went to activate the safety device of the 23g 1 and 1/2" dps safety needle.The vaccinator used their hand to close the safety device; however, as they applied pressure to the syringe/needle the neck of the caretouch 1ml syringe (connecting it to the needle) broke.The needle then fell and punctured finger of the vaccinator.Fda safety report id# (b)(4).

• Brand Name: CARE TOUCH 1ML SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): FUTURE DIAGNOSTICS, LLC.
• MDR Report Key: 11618663
• MDR Text Key: 244180556
• Report Number: MW5100552
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization