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

Model Number 481012

Device Problem Difficult to Open or Close (2921)

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

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

Information provided is not adequate.Should more information be available supplemental report will be submitted.

Event Description

Clamp on smartez 100 ml.200 "ml/ml" (model# se0200-100.Lot s8c58) filled with 0.9% sodium chloride 90 ml would not close.

• Brand Name: SMARTEZ PUMP
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.; epic international (thailand); 500/73 moo 2, tasit; pluakdaeng, rayong 21140 ; TH 21140
• Manufacturer (Section G): EPIC INTERNATIONAL (THAILAND) CO., LTD.; epic international (thailand); 500/73 moo 2, tasit; pluakdaeng, rayong 21140 ; TH 21140
• Manufacturer Contact: david lennarz ; registrar corp; 144 research drive; hampton, va 23666 ; 7572240177
• MDR Report Key: 8272150
• MDR Text Key: 134204369
• Report Number: 3012429465-2019-00025
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 28859299101013
• UDI-Public: (01)28859299101013(10)S8C58(17)210228(11)180328(241)SE0200-100
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 481012
• Device Lot Number: S8C58
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1