MAUDE Adverse Event Report: NEOMED, INC. ENFIT 1 ML SYRINGES; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS

Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Type  No Answer Provided  

Event Description

Neomed enfit 0.5ml and 1ml syringes have an extended plunger to eliminate dead space in syringe tip.This extended plunger has been incorrectly utilized as the measuring mark, resulting in a potential under dose.In addition, the volume is displaced when the cap is applied.(b)(6).

• Brand Name: ENFIT 1 ML SYRINGES
• Type of Device: ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): NEOMED, INC.
• MDR Report Key: 12287665
• MDR Text Key: 265844079
• Report Number: MW5103053
• Device Sequence Number: 2
• Product Code: PNR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/05/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1