FDA Adverse Event
Malfunction
Summary report: N
MEDICCHOICEUMBILICAL CORD CLAMP
MDR report key: 19559999
·
Received June 17, 2024
Report
- Report Number
- MW5156364
- Event Type
- Malfunction
- Date Received
- June 17, 2024
- Date of Event
- June 12, 2024
- Report Date
- June 13, 2024
- Manufacturer
- MEDICHOICE/CYPRESS MEDICAL PRODUCTS LLC
- Product Code
- HFW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
INFANT BORN AT 1222 TODAY AND WAS SKIN TO SKIN IN THE RECOVERY ROOM WITH MOTHER. THE BABY RN (REGISTERED NURSE) WAS CHECKING VITAL SIGNS AND DISCOVERED THERE WAS BLEEDING FROM THE UMBILICAL CORD. BABY AND MOTHER WITH BLOOD ALL OVER. PRESSURE APPLIED TO CORD AND NEO ARNP CALLED AND CAME RIGHT AWAY TO BEDSIDE. NEW UMBILICAL CLAMP APPLIED, NEWBORN DRIED. BABY RN NOTIFIED MYSELF, MNB ANM AND I RESPONDED TO BEDSIDE. NEWBORN WELL APPEARING ON ASSESSMENT. ARNP VISUALLY ESTIMATES 5-7ML BLOOD LOSS. APPEARS CLAMP SLID OFF END OF CORD. ARNP (ADVANCED PRACTISE NURSE PRACTITIONER) DISCUSSED WHAT HAPPENED WITH PARENTS, ANSWERED QUESTIONS. PLAN IS FOR H&H IN 6HRS. DART RN (DISTRESS ACTIVATION RESPONSE TEAM REGISTERED NURSE) UPDATED ON EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1511868 | MEDICCHOICEUMBILICAL CORD CLAMP | CLAMP, UMBILICAL | HFW | MEDICHOICE/CYPRESS MEDICAL PRODUCTS LLC | M08246GD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DA | Male |