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

Catalog Number 686304/B

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

The suspect device is not returning for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

Event Description

The account alleges that a leak was identified near the arterial line connection.The device was replaced.No patient injury to report.

Manufacturer Narrative

The suspect device was returned for evaluation.The complaint was originally reported as a leak at the connector, however, visual examination of the returned device found the connector to be detached.The root cause is attributed to the manufacturing process.A review of the device history record was performed and no exception documents were found.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: 8164209
• MDR Text Key: 130348602
• Report Number: 8020616-2018-00083
• Device Sequence Number: 1
• Product Code: DSK
• 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: 11/16/2018

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 Catalogue Number: 686304/B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1