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

Catalog Number 689615/JPB

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2021

Event Type  malfunction  

Event Description

The account alleges that during the hemodynamic monitoring of a patient, the pressure monitoring [pm] set was found to be leaking fluid from the connections.Blood was also noted to be backing up in the line after priming the device.The pm set was exchanged, and the procedure was successfully completed.No additional patient consequences to report.

Manufacturer Narrative

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

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: SAFEDRAW¿
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, 76892 6; SN 768926
• Manufacturer (Section G): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, 76892 6; SN 768926
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 13048257
• MDR Text Key: 284986094
• Report Number: 8020616-2021-00098
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00884450447659
• UDI-Public: 884450447659
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

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 Expiration Date: 12/18/2022
• Device Catalogue Number: 689615/JPB
• Device Lot Number: C2182349S1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 01/17/2022
• Supplement Dates FDA Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1