MAUDE Adverse Event Report: LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD VASC BAND; HEMOSTAT

Model Number 3524

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 07/07/2023

Event Type  Injury  

Event Description

It was reported that: the vascband air self-deflating.Hematoma formed compression held.

Manufacturer Narrative

Email to consult questions: may i ask how long was the deflation discovered? where is the location point? can you explain the detailed operation process of medical staff? how much does it start to inflate? how long will the subsequent air extraction operation be carried out and how will the extraction operation be carried out? can abnormal products be returned for cause analysis? what is the size of the patient's hematoma? what medical interventions did the doctor perform? what is the final result? and got response: no more valid information obtained from the hospital.Tracing the dhr records and production inspection records of lot 202303935, there were no abnormalities.The production inspection process of the product was strictly carried out in accordance with the work instructions.The relaxation of the product airbag needs to undergo a full production inspection, and the airbag strength has undergone quality sampling inspection.The production process quality of the product is stable and reliable.Tested the retention samples of lot 202303935, and there were no abnormalities in the airbag relaxation test and airbag strength test.The problem in the customer complaint was about the patient's hematoma problem after pci.In response to this situation, the literature "nursing care of using arterial compressors to stop hemostasis after pci through the radial artery" lists common nursing issues when using compressors.If a hematoma occurs, as described in 3.1.1, nursing staff should fix the compression pad with one thumb, adjust the elasticity of the elastic band with the other hand, and designate a range to observe whether the hematoma has changed.For limb swelling, monitor changes in arm circumference, and compare the two upper limb arm circumferences.Observe closely within 15 minutes after surgery, then every 30 minutes, and gradually relax until removal after 4 hours.If there is a hematoma in the puncture area and subcutaneous congestion in the forearm, as described in 4.3, and a hematoma appears above the puncture, an additional hemostat can be added above the hemostat to pressurize and extend the compression time of the hemostat appropriately; pencil hematoma can be treated with pressure on the cuff of a blood pressure gauge for 10 minutes, followed by bandage compression at the spot to prevent serious bleeding.After surgery, local ice packs should be used for cold compress, and close attention should be paid to the peripheral blood supply of the hand, paying attention to the patient's complaints.No more valid information was not provide, and our company is unable to clarify the cause of this abnormal occurrence, therefore we are unable to accurately analyze the root cause of the adverse event.

• Brand Name: VASC BAND
• Type of Device: HEMOSTAT
• Manufacturer (Section D): LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD; no.37 chaoqian rd.; changping district; beijing, 10220 0; CH 102200
• Manufacturer (Section G): LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD; no.37 chaoqian rd.; changping district; beijing, 10220 0; CH 102200
• Manufacturer Contact: bo jiang ; no.37 chaoqian rd.; changping district; beijing, 10220-0 ; CH 102200
• MDR Report Key: 18145977
• MDR Text Key: 328225252
• Report Number: 3008002401-2023-00005
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 10841156102043
• UDI-Public: (01)10841156102043(17)250330(10)202303935
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 3524
• Device Lot Number: 202303935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2023
• 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): Required Intervention