MAUDE Adverse Event Report: LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD VASCBAND; CLAMP, VASCULAR

Model Number	IPN914174
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Vasc band hemostat opened to sterile field and tested by inflating with 20ml air.Plastic piece fell off of vasc band.
Additional Manufacturer Narrative
Investigation record: (1) sent an email to the distributor inquiring about: whether the product's appearance and condition were checked before use? how exactly did the medical staff operate the compressor? whether any video materials were retained for root cause analysis.No response has been received from the distributor.(2) traced the dhr (device history record) and production inspection records for batch: 202408922.No abnormalities were found in the finished product inspection records.Our compressors were manufactured and inspected strictly in accordance with the operating procedures.The products underwent full inspection during production and random inspection during quality control.The production process was stable and reliable, with no similar issues identified.(3) conducted tests on the retained samples from batch: 202408922.The product's appearance and structure showed no abnormalities.Simulation of the usage conditions described in the customer feedback also did not result in the support plate falling off.Investigation conclusion.Since the product was not returned and no additional effective information regarding the product abnormality or specific operation details was obtained, the root cause of this customer complaint remains unclear at this time.

• Brand Name: VASCBAND
• Common Device Name: CLAMP, VASCULAR
• 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, beijing 10220 0; CH 102200
• Manufacturer Contact: bo jiang ; no.37 chaoqian rd.; changping district; beijing, beijing 10220-0 ; CH 102200
• MDR Report Key: 22901644
• Report Number: 3008002401-2025-00001
• Device Sequence Number: 7932728
• Product Code: DXC
• UDI-Device Identifier: 10841156102043
• UDI-Public: (01)10841156102043(17)260824(10)202408922
• Combination Product (Y/N): N
• PMA/510(K) Number: K142359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/18/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2026
• Device Model Number: IPN914174
• Device Catalogue Number: 3524
• Device Lot Number: 202408922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Unknown
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic