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

Model Number	484012
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record for the reported lot number was reviewed and confirmed that the lot was manufactured according to the approved manufacturing procedures.Retained samples were also tested and passed.There is no patient involvement.There is no adverse event.
Event or Problem Description
Three (3) smartez pumps (se0200-100, lot# s7n32) began leaking at the bottom shoulder where the bladder meets the bottom ring, when the tech started filling with 0.9% sodium chloride.

• Brand Name: SMARTEZ PUMP
• Common Device Name: ELASTOMERIC PUMP
• Manufacturer (Section D): EPIC INTERNATIONAL (THAILAND) CO., LTD.; hemaraj eastern seaboard indus; 500/73 moo 2, tasit; pluakdaeng, rayong 21140 ; TH 21140
• MDR Report Key: 8350435
• Report Number: 3012429465-2019-00052
• Device Sequence Number: 1825966
• Product Code: MEB
• UDI-Device Identifier: 28859299101013
• UDI-Public: (01)28859299101013(10)S7N32(17)201128(11)1228(241)SE0200-100
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2020
• Device Model Number: 484012
• Device Lot Number: S7N32
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1