MEDICHOICE
Received Dec 20, 2025 · Event occurred Sep 24, 2024
Report 3004824601-2025-00216 · MDR key 23858590
Device
Generic name
Umbilical Cord Clamps
Manufacturer
Jiangsu Guangda Medical Material Group Co., LtdModel number
CLMP101Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
NA · Unknown
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
ON (B)(6) 2024, CUSTOMER REPORTED THAT CLMP101 MEDICHOICE UMBILICAL CORD CLAMP SLID OFF AN INFANT'S UMBILICAL CORD AFTER BIRTH, CAUSING THE INFANT TO LOSE 5-7 ML OF BLOOD FROM THE UMBILICAL CORD. MEDICAL INTERVENTION WAS REQUIRED AND A NEW UMBILICAL CLAMP WAS APPLIED. UPON ASSESSMENT, NEWBORN APPEARED WELL. HEMOGLOBIN & HEMATOCRIT TREATMENT WAS RECOMMENDED.
Additional Manufacturer Narrative
THESE MEDICAL DEVICE REPORTS (MDRS) ARE BEING FILED PAST THE REGULATORY REPORTING TIMEFRAME AS THEY ARE A RESULT OF A RETROSPECTIVE REVIEW OF OUR COMPLAINTS. AN INVESTIGATION WAS CONDUCTED BY ASP GLOBAL AND THE MANUFACTURER. DUE TO LIMITED INFORMATION AND LACK OF PRODUCT SAMPLES, A ROOT CAUSE COULD NOT BE IDENTIFIED. NO SERIOUS INJURY WAS REPORTED, AND THERE WAS INSUFFICIENT INFORMATION TO DETERMINE WHETHER A MALFUNCTION OCCURRED.