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

Model Number SE0200-100

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 05/28/2019

Event Type  malfunction  

Event Description

Fifteen devices had a cracked stem discovered while filling with ns.Smartez pump (se0200-100, lot# s8a28).Fda safety report id# (b)(4).

• Brand Name: SMARTEZ 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: 8658374
• MDR Text Key: 146923638
• Report Number: MW5087027
• Device Sequence Number: 8
• 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: 05/29/2019
• 15 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SE0200-100
• Device Lot Number: S8A28
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1