MAUDE Adverse Event Report:; Syringe, piston

Device Problems Product Quality Problem (1506); Incomplete or Missing Packaging (2312); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)

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

Event Date 08/23/2022

Event Type  malfunction  

Manufacturer Narrative

End user did not provide an item number or lot number from the reported product malfunctions.Closed due to insufficient information.

Event Description

End user reports that syringes purchased from amazon have been missing caps and the needles are burred.User also reports that some of these syringes are missing the finger grips but are not lose in the poly bags.End user did not provide an item number or lot number from the reported product malfunctions.

• Type of Device: Syringe, piston
• Manufacturer Contact: troy smith ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 15432765
• MDR Text Key: 306174295
• Report Number: 3005798905-2022-03077
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/23/2022
• 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