MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW¿; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number	682000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
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, blood was observed to be going backward.The set was found to be leaking between the blood sample port and the tubing.No patient injury to report.
Additional Manufacturer Narrative
The suspect device was returned for investigation.The device was examined visually.Functional testing was performed.The complaint is confirmed.The root cause is attributed to the manufacturing process.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: SAFEDRAW¿
• Common Device Name: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, sgp 76892 6; SN 768926
• Manufacturer (Section G): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, sgp 76892 6; SN 768926
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 14439185
• Report Number: 8020616-2022-00029
• Device Sequence Number: 5579208
• Product Code: DXN
• UDI-Device Identifier: 00886333620005
• UDI-Public: 00886333620005
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K935782
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

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 Expiration Date: 10/15/2023
• Device Model Number: 682000
• Device Catalogue Number: 688410/B
• Device Lot Number: C2257946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown