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

Catalog Number 689311

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/01/2018

Event Type  malfunction  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that the art line/transducer system was leaking blood at the septum during monitoring on an adult patient.No patient injury to report.

Manufacturer Narrative

The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.A review of the device history record and complaint database could not be performed since a lot number was not provided.

• 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: 7954431
• MDR Text Key: 123691332
• Report Number: 8020616-2018-00050
• 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: 09/11/2018

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: 689311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Manufacturer Received: 09/11/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 11/22/2018
• Supplement Dates FDA Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1