|
Model Number 5079181 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
A2: age: 45 years, sex: female.E.1:complainant street address: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number , reporting site: 1049092 , manufacturing site: 3005778470.
|
|
Event Description
|
It was reported, 'many products have been flat and tied together so you can¿t really open it.The safety-paper has been pushed together with the opening.The catheters are difficult to tear apart, they have been destroyed for usage in the packaging, most likely during transport'.Sterile product packaging was 'open upon receipt'.
|
|
Search Alerts/Recalls
|
|
|