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

Catalog Number 686304/B

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 09/17/2019

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 device was found to be leaking blood from the septum.The device was replaced with no additional consequences to the patient.

Manufacturer Narrative

The suspect device was not returned for evaluation however a photo was provided.The complaint could not be confirmed.The root cause could not be determined however the tubing detachment could be related to the manufacturing processes.A search of the complaint database was performed and one similar complaint for this lot number was found.The device history record was reviewed, and no exception documents were found.Corrective actions are in process.

• Brand Name: SAFEDRAW BLOOD SAMPLING SET
• Type of Device: BLOOD SAMPLING SET
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, 76892 6; SN 768926
• MDR Report Key: 9176879
• MDR Text Key: 196743116
• Report Number: 8020616-2019-00117
• Device Sequence Number: 1
• Product Code: DSK
• Combination Product (y/n): N
• PMA/PMN Number: K885235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

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: 11/30/2023
• Device Catalogue Number: 686304/B
• Device Lot Number: C1461994
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2019
• Initial Date FDA Received: 10/10/2019
• Supplement Dates Manufacturer Received: 10/25/2019
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1