FDA Adverse Event
Other
Summary report: N
RSP ENDOTRACHEAL TUBE HOLDER
MDR report key: 275976
·
Received April 29, 2000
Report
- Report Number
- 2020364-2000-00002
- Event Type
- Other
- Date Received
- April 29, 2000
- Date of Event
- March 4, 2000
- Report Date
- April 26, 2000
- Manufacturer
- SIMS/RESPIRATORY SUPPORT PRDTS.
- Product Code
- CBH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE NURSE TECHNICIAN REPORTED, IN THE PRESENCE OF THE REGISTERED NURSE, THAT A 24 WEEK OLD FEMALE INFANT, (WEIGHT 800 GRAMS), EXTUBATED. THE COMPLAINANT IS USING RSP ENDOTRACHEAL TUBE HOLDER, H4051, SIZE 2.5, WITH A PORTEX TUBE. THE LOCK CAME OFF AND WAS FOUND IN THE INFANT'S BED. ORAL SECRETIONS WERE AVERAGE. THE INFANT WAS SUCTIONED APPROXIMATELY 2 HRS PRIOR TO THE EVENT. THE INFANT WAS RE-INTUBATED WITHOUT INCIDENT. THE PRODUCT WAS NOT SAVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RSP ENDOTRACHEAL TUBE HOLDER | ENDOTRACHEAL TUBE HOLDER | CBH | SIMS/RESPIRATORY SUPPORT PRDTS. | H4051 | 1489 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 MO | Other |