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

Model Number 481012

Device Problem Particulates (1451)

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

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.Visual inspection revealed that the particle was in solution.No other signs of abnormality were observed.The reported condition was verified.The cause of the condition was not determined.

Event Description

Smartez pump (se0200-100, lot# s8d33) containing cefazolin 2 gram (batch rx# h938108 , mix date (b)(6) 2018) in 0.9% sodium chloride 100 ml had a particulate floating in solution.

• Brand Name: SMARTEZ PUMP
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.; hemaraj eastern seaboard indus; 500/73 moo 2, tasit; pluakdaeng, rayong 21140 ; TH 21140
• Manufacturer (Section G): EPIC INTERNATIONAL (THAILAND) CO., LTD.; hemaraj eastern seaboard indus; 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: 8350422
• MDR Text Key: 137273176
• Report Number: 3012429465-2019-00030
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 28859299101013
• UDI-Public: (01)28859299101013(10)S8D33(17)210328(11)180428(241)SE0200-100
• Combination Product (y/n): N
• PMA/PMN Number: K151650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial
• Report Date: 01/25/2019

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: 03/28/2021
• Device Model Number: 481012
• Device Lot Number: S8D33
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2018
• 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