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

Model Number	10884450372514
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: BLOOD SAMPLING SYSTEM
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, 76892 6; SN 768926
• MDR Report Key: 10254616
• Report Number: 8020616-2020-00034
• Device Sequence Number: 2779991
• Product Code: DSK
• UDI-Device Identifier: 10884450372514
• UDI-Public: 10884450372514
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K885235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2020

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 Model Number: 10884450372514
• Device Catalogue Number: 688721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 07/26/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1