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

Model Number SE0200-100

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2019

Event Type  malfunction  

Event Description

Smartez pump (se0200-100, lot# s8a24, exp 12/28/2020) containing ceftriaxone 2 grams in 0.9% sodium chloride 100 ml, immediately began leaking from under the white ring at the top of the device once mixed.Fda safety report id# (b)(4).

• Brand Name: SMARTEZ ELASTOMERIC PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD. ; tasit; pluakdaeng, rayong 21140 TH; TH 21140 TH
• MDR Report Key: 8612110
• MDR Text Key: 145228275
• Report Number: MW5086640
• 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: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2020
• Device Model Number: SE0200-100
• Device Lot Number: S8A24
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1