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

Model Number 682000

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/11/2020

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 from the 3-way stopcock.The pm set was exchanged, and the procedure was successfully completed with no consequences to the patient.

Manufacturer Narrative

The suspect device has been returned for evaluation.Functional test was conducted using saline set-up pressurized at 300mmhg and leakage was found from the planecta stopcock housing.The complaint is confirmed.The root cause could not be determined however, the cracked propagation on the housing could be likely due to force or weight applied onto the planecta resulted to mechanical stress outside and incurred during procedure.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 BLOOD SAMPLING SYSTEM
• Type of Device: BLOOD SAMPLING SYSTEM
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE; 198 yishun ave 7; singapore, 76892 6; SN 768926
• MDR Report Key: 10485821
• MDR Text Key: 205482744
• Report Number: 8020616-2020-00044
• Device Sequence Number: 1
• Product Code: DSK
• UDI-Device Identifier: 00886333620005
• UDI-Public: 00886333620005
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2022
• Device Model Number: 682000
• Device Catalogue Number: 689615/JPA
• Device Lot Number: C1778088
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 68