|
Model Number BCFG741002 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
According to the available information, the item number was a 7 ch/fr device; however, the stent in the package was 8 ch/fr.The pusher was 7 ch/fr, so the connection did not fit intraoperatively.
|
|
Manufacturer Narrative
|
D4 lot number: 9070782.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.
|
|
Manufacturer Narrative
|
We have been informed about a defect product: jj in ch.8 in the packaging according to the complaint description, the sample are available and the lot number.After receiving this complaint, we searched for other complaints with the same lot number 9070782 we found four other complaints checking the quality database revealed no anomaly in relation with the describe defect.On july we received sealed sample.After observation we note that jj item number ycv284 ch8 were packaged instead of jj item number ych17490 ch7 were packaged.Production unit for this product was informed about this defect.An awareness was already done about this topic on may.Similar case study was done based on same item number, same defect ( packaging/labelling error), over last four year, and 5 others complaints (same issue but duplicate for emdr).
|
|
Search Alerts/Recalls
|
|
|