MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW BLOOD SUPPLY SYSTEM

Catalog Number 688420

Device Problem Infusion or Flow Problem (2964)

Patient Problems Air Embolism (1697); Erosion (1750); Tissue Damage (2104); Thromboembolism (2654)

Event Date 03/01/2015

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A review of the device history and complaint database could not be performed since the lot number was not provided.

Event Description

The patient's legal counsel alleges that an icu patient experienced a circulatory problem within the left index finger and hand of this patient.It was also alleged that air bubbles or clots within the pressure line may have contributed to this problem, and allegedly resulted in the amputation of the thumb and index finger of the patient's left hand.

• Brand Name: SAFEDRAW BLOOD SUPPLY SYSTEM
• Type of Device: BLOOD SUPPLY SYSTEM
• 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: katie swenson cqe,cba,cqpa. ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 8056278
• MDR Text Key: 126704137
• Report Number: 8020616-2018-00061
• Device Sequence Number: 1
• Product Code: DSK
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K885235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 688420
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Disability