MAUDE Adverse Event Report: APOTHECARY PRODUCTS, LLC EZY DOSE 5ML; ORAL SYRINGE

Lot Number 050316

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 06/23/2016

Event Type  malfunction  

Event Description

From our distributor we received an ezy dose 10 ml oral syringe with packaging for a 5 ml syringe.This happened on (b)(6).On both occasions, we contacted the distributor and the mfr to let them know that the syringe packaging was incorrect.I do have picture if you'd like to review them.Info was also sent to (b)(6).

• Brand Name: EZY DOSE 5ML
• Type of Device: ORAL SYRINGE
• Manufacturer (Section D): APOTHECARY PRODUCTS, LLC; minneapolis MN 55337
• MDR Report Key: 5754460
• MDR Text Key: 48460957
• Report Number: MW5063060
• Device Sequence Number: 1
• Product Code: KYW
• UDI-Device Identifier: 2571567008
• UDI-Public: 2571567008
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 050316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1