FDA Adverse Event
Malfunction
Summary report: N
UMBILICAL CLAMP
MDR report key: 140332
·
Received December 22, 1997
Report
- Report Number
- 1648571-1997-00010
- Event Type
- Malfunction
- Date Received
- December 22, 1997
- Date of Event
- November 20, 1997
- Manufacturer
- QFC PLASTICS
- Product Code
- HFW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
BABY WAS IN WARMER ABOUT 10 MINUTES AND THEN WAS HANDED TO HIS MOTHER. THE NURSE ADJUSTED THE POSITION OF THE BABY AND MOTHER, WHEN SHE NOTICED A CONSIDERABLE BLOOD STAIN - 6-8", WHICH SATURATED THROUGH TWO BLANKETS AND ONTO THE MOTHER'S NIGHTGOWN, WHEN INVESTIGATING THE STAIN ON THE BABY'S BLANKET, THE UMBILICAL CLAMP WAS FOUND TO BE OPEN. A HEMOSTAT WAS IMMEDIATELY APPLIED UNTIL ANOTHER CLAMP COULD BE BROUGHT IN. THE INFANT'S BLOOD SUGARS WERE CHECKED AND FOUND TO BE OK. MOTHER AND INFANT WERE KEPT AN ADDITIONAL 12 HOURS FOR OBSERVATION, THEN RELEASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UMBILICAL CLAMP | UMBILICAL CLAMP | HFW | QFC PLASTICS | QFC-650 | 163-97 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DAY | Required Intervention |