InjuryHFW
UMBILICAL CORD CLAMP
Received Oct 26, 2018 · Event occurred Sep 26, 2018
Report 8008632 · MDR key 8008632
Device
Generic name
Umbilical Cord Clamp
Manufacturer
Hollister IncorporatedModel number
9423Catalog number
9423
Lot number
NI
Product problems
- Detachment of Device or Device Component
Patient
1 DA
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
UMBILICAL CORD CLAMP CAME OFF A BABY. FATHER CAUGHT IT AND BLEEDING WAS MINIMAL.
Additional Manufacturer Narrative
A REVIEW OF COMPLAINT HISTORY FOR THIS PRODUCT REVEALED NO SIMILAR REPORTED INCIDENTS.
Description of Event or Problem
THE UNIT WAS APPLIED BY THE PEDIATRICIAN IN THE OPERATING ROOM AFTER BIRTH. APPROXIMATELY 16 HOURS LATER, THE UNIT CAME OFF THE BABY. THE FATHER CAUGHT IT AND BLEEDING WAS MINIMAL. PRESSURE WAS APPLIED AND THE CORD WAS TIED OFF WITH UMBILICAL TAPE.