MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW BLOOD SUPPLY SYSTEM

Catalog Number 689312/B

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during the hemodynamic monitoring of a patient, the membrane of septum was found to be leaking and bulging when flushing the device.No patient injury to report.

Manufacturer Narrative

The suspect device was returned for evaluation.Visual examination and functional testing were conducted on the returned sample and no defect was observed and the device performed as expected without leaking.The complaint was not confirmed.The root cause could not be identified.Based on analysis and evaluation conducted on the returned sample, the cause of leaking and bulging when flushing could be due to the excessive fluid volume injected on the system exceeding 300mmhg from the septum membrane.A dhr review was performed and yielded no exception documents.A review of the complaint database was performed and no similar complaints for this lot number were found.

• Brand Name: SAFEDRAW BLOOD SUPPLY SYSTEM
• Type of Device: BLOOD SUPPLY SYSTEM
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, 76892 6; SN 768926
• MDR Report Key: 9799482
• MDR Text Key: 193082445
• Report Number: 8020616-2020-00014
• Device Sequence Number: 1
• Product Code: DSK
• UDI-Device Identifier: 00088633362132
• UDI-Public: 0088633362132
• Combination Product (y/n): N
• PMA/PMN Number: K885235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 689312/B
• Device Lot Number: C1637964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1