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

Catalog Number 688875

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2020

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 a luer connecter at the tip of a planecta, loosened immediately after it was connected.

Manufacturer Narrative

The suspect device was returned for evaluation.The device was examined visually.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: SAFEDRAW BLOOD SAMPLING SYSTEM
• Type of Device: BLOOD SAMPLING SYSTEM
• Manufacturer (Section D): MERIT MEDICAL SIGAPORE PTE LTD; 198 yishun ave 7; sn, sgp 76892 6; SN 768926
• MDR Report Key: 10141383
• MDR Text Key: 202518089
• Report Number: 8020616-2020-00031
• Device Sequence Number: 1
• Product Code: DSK
• Combination Product (y/n): N
• PMA/PMN Number: K935782
• 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: 05/14/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 688875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Manufacturer Received: 05/14/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 07/02/2020
• Supplement Dates FDA Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1