Model Number H74939134404010 |
Device Problem
Contamination (1120)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 07/14/2014 |
Event Type
malfunction
|
Event Description
|
It was reported that during unpacking device contamination occurred.A 4mm x 40mm x 145cm coyote¿ es balloon catheter was removed from the package when the device flip to the side and was unsterile.The device was not used.The procedure was completed with a different device.No patient complications were reported.
|
|
Manufacturer Narrative
|
(b)(4).
|
|
Manufacturer Narrative
|
Device evaluated by mfr.; visual inspection showed the hub of the device was protruding out the side of the opened product pouch 4mm.The carrier tube (hoop) was positioned in the product pouch with the hub of the device under the tyvek section against the edge of the vendor seal.Inspection of the remainder of the device and packaging revealed no damage or irregularities.No issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred prior to patient contact.(b)(4).
|
|
Event Description
|
It was reported that during unpacking device contamination occurred.A 4mm x 40mm x 145cm coyote es balloon catheter was removed from the package when the device flip to the side and was unsterile.The device was not used.The procedure was completed with a different device.No patient complications were reported.
|
|
Search Alerts/Recalls
|