FDA Adverse Event
Malfunction
Summary report: N
DALE PEDIATRIC TRACHEOSTOMY TUBE HOLDER
MDR report key: 2190555
·
Received October 16, 2007
Report
- Report Number
- 1214422-2007-00010
- Event Type
- Malfunction
- Date Received
- October 16, 2007
- Date of Event
- September 22, 2007
- Report Date
- October 15, 2007
- Manufacturer
- DALE MEDICAL PRODUCTS
- Product Code
- CBH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE NURSE ADVISES THAT FASTENER TABS WERE ATTACHED PROPERLY BUT NECK BAND WAS STRETCHED OUT. THE PRODUCT WAS UNAVAILABLE FOR REVIEW. SAMPLES FROM STOCK WERE TESTED AT DALE MEDICAL PRODUCTS, BUT THE ALLEGATION COULD NOT BE DUPLICATED. THE PRODUCT PERFORMED PER SPECIFICATIONS.
Description of Event or Problem · 1
THE NURSE WAS MONITORING THE PT AND OBSERVED THAT THE PT HAD DECANNULATED WHILE WEARING THE DALE TRACHEOSTOMY TUBE HOLDER. THE TRACHEOSTOMY TUBE WAS REINSERTED WITH GOOD OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DALE PEDIATRIC TRACHEOSTOMY TUBE HOLDER | 242 BLUE | CBH | DALE MEDICAL PRODUCTS | 242 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 MO | Required Intervention |