FDA Adverse Event
Other
Summary report: N
NUCLETRON MICROSELCTRON
MDR report key: 2982480
·
Received October 18, 2007
Report
- Report Number
- 9611894-2006-00002
- Event Type
- Other
- Date Received
- October 18, 2007
- Date of Event
- September 26, 2006
- Report Date
- October 16, 2006
- Manufacturer
- NUCLETRON B.V.
- Product Code
- JAQ
- PMA / PMN Number
- K953946
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PROBLEM WITH THE TRANSFER TUBES WAS IDENTIFIED DURING PRODUCTION. USER FACILITIES HAVE NOT REPORTED PROBLEMS RELATED TO AN INCREASE IN LENGTH OF THE TRANSFER TUBE. SEE SCANNED PAGE.
Description of Event or Problem · 1
THE CRIMPING OF THE TRANSFER TUBE COUPLINGS HAS FOUND TO BE INADEQUATE ON RECENTLY MANUFACTURED TRANSFER TUBES. WITH INADEQUATE CRIMPING, THE COUPLING CAN SLIDE OVER THE TRANSFER TUBE MATERIAL. AS A RESULT, THE TRANSFER TUBE CAN ELONGATE. IF FORCE IS APPLIED, THE OVERALL LENGTH OF THE TRANSFER TUBE COULD INCREASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLETRON MICROSELCTRON | JAQ REMOTE AFTERLOADER ACCESSRY | JAQ | NUCLETRON B.V. | 009979 | 079293-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |