MAUDE Adverse Event Report: EPIC INTERNATIONAL (THAILAND) CO., LTD. SMARTEZ PUMP; PUMP, INFUSION, ELASTOMERIC

Model Number SE0005-125

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2021

Event Type  malfunction  

Event Description

Smart ez pump 125ml at 5 ml/hr reference number 480031, lot s20l13 leaked and continued to leak from the fill port until all contents emptied.Fda safety report id# (b)(4).

• Brand Name: SMARTEZ PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.
• MDR Report Key: 12814722
• MDR Text Key: 280935778
• Report Number: MW5105322
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• 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: 11/10/2021

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 Expiration Date: 09/28/2023
• Device Model Number: SE0005-125
• Device Catalogue Number: 480031
• Device Lot Number: S20L13
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 MO
• Patient Sex: Female
• Patient Weight: 11 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White