FDA Adverse Event
Malfunction
Summary report: N
THIN TANDEM TUBE
MDR report key: 2422844
·
Received December 23, 2011
Report
- Report Number
- 9611894-2011-00015
- Event Type
- Malfunction
- Date Received
- December 23, 2011
- Date of Event
- March 3, 2010
- Report Date
- December 23, 2011
- Manufacturer
- NUCLETRON
- Product Code
- JAQ
- PMA / PMN Number
- K983341
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AS A PRECAUTION ALL APPLICATOR USER MANUALS WERE UPDATED WITH THE SAME INSTRUCTIONS AS IN THE AFTERLOADER MANUAL. AS A RESULT OF THE FDA FORM 483 REPORT FEI NUMBER (B)(4) DATED (B)(4), 2011, NUCLETRON BV IS NOW SUBMITTING THIS MDR IN COMPLIANCE WITH THE CORRECTIVE ACTIONS OF THE FDA FORM 483.
Description of Event or Problem · 1
CUSTOMER COMPLAINED OF QA ERROR FOR THIN TANDEM TUBE. THERE WAS POTENTIAL MIS-TREATMENT OF PT DUE TO INCORRECT RECONSTRUCTION OF TANDEM, WHEN NOT USING MARKER WIRE, AND NOT AWARE OF THE CHANGE IN TANDEM LENGTH DUE TO THE EXTRA END CAP. THIS ISSUE WAS DISCOVERED AS A RESULT OF THE PRESCRIBED QA BY THE AFTERLOADER USER MANUAL PRIOR TO TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THIN TANDEM TUBE | STANDARD CT/MR APPLICATOR SET, RING CT/M | JAQ | NUCLETRON | 101.035 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |