MAUDE Adverse Event Report: HTL-STREFA S.A. DROPSAFE SYRINGE WITH SAFETY NEEDLE

Model Number 25G X 1

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

The syringes that we have received to administer covid-19 vaccine that are defective.Locking mechanism for attaching needle to syringe is defective and it will not securely lock on.This kind of problem resulted in patient having a vaccine partially administered as it began leaking significantly from the union while being administered.

• Brand Name: DROPSAFE SYRINGE WITH SAFETY NEEDLE
• Type of Device: SYRINGE WITH SAFETY NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• Manufacturer (Section G): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• Manufacturer Contact: aleksandra prazmowska-wilanowska ; adamowek 7; ozorkow, 95-03-5 ; PL 95-035
• MDR Report Key: 11870135
• MDR Text Key: 259350592
• Report Number: 9613304-2021-00019
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K170651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial
• Report Date: 04/24/2021

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: Health Professional
• Device Model Number: 25G X 1
• Device Catalogue Number: 6054
• Device Lot Number: 0325250004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2021
• 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: Unknown
• Patient Sequence Number: 1