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

Model Number 10884450372514

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/18/2020

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 during the hemodynamic monitoring of a patient, the pressure monitoring [pm] set was found to be leaking fluid.Air ingress from a planecta stopcock was found after a patient was transferred from operating room to icu.Crack could not be found during visual observation.No patient injury to report.

Manufacturer Narrative

The suspect device was returned for evaluation.The device was examined visually, and functional testing was performed.The complaint was confirmed and the root cause attributed to the mechanical stress incurred during procedural use.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 SAMPLING SYSTEM
• Type of Device: BLOOD SAMPLING SYSTEM
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, 76892 6; SN 768926
• MDR Report Key: 10254616
• MDR Text Key: 202254435
• Report Number: 8020616-2020-00034
• Device Sequence Number: 1
• Product Code: DSK
• UDI-Device Identifier: 10884450372514
• UDI-Public: 10884450372514
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10884450372514
• Device Catalogue Number: 688721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Date Manufacturer Received: 07/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1