• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FUTURE DIAGNOSTICS, LLC. CARE TOUCH 1ML SYRINGE SYRINGE, PISTON Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCARE TOUCH 1ML SYRINGE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
FUTURE DIAGNOSTICS, LLC.
MDR Report Key11618663
MDR Text Key244180556
Report NumberMW5100552
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
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 Received04/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 04/05/2021 Patient Sequence Number: 1
-
-