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

Catalog Number 689041/A

Device Problems Loose or Intermittent Connection (1371); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2018

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 customer alleges that the rotating adapter at the end of the arterial line, before the patient line, can't be fastened tight enough and sometimes when the patient moves the arterial line detaches.No patient injury to report.

Manufacturer Narrative

One device has been returned for evaluation.The product was examined visually.The complaint could not be confirmed.No definitive root cause could 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 BLOOD SAMPLING SET
• Type of Device: BLOOD SAMPLING SET
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; 76892 6; SN 768926
• MDR Report Key: 7555342
• MDR Text Key: 109621021
• Report Number: 8020616-2018-00006
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/05/2018

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: 689041/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 07/16/2018
• Supplement Dates FDA Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARTERIAL CANNULA