Model Number 7212 |
Device Problem
Device Misassembled During Manufacturing /Shipping (2912)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/22/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that labeling issue occurred.During unpacking of a 2.75mm x 12mm nc emerge balloon, it was noted that a 3.00mm x 12mm nc emerge was found inside the box instead.The procedure was completed and no patient complications were reported.
|
|
Event Description
|
It was reported that labeling issue occurred.During unpacking of a 2.75mm x 12mm nc emerge balloon, it was noted that a 3.00mm x 12mm nc emerge was found inside the box instead.The procedure was completed and no patient complications were reported.
|
|
Manufacturer Narrative
|
D4: lot number updated from 0026110442 to 0025497152.D4: expiration date update from 10/01/2022 to 05/07/2022.D4: unique identifier (udi) update from (b)(4) to (b)(4).H4: device manufacture date update from 10/01/2020 to 05/07/2020.
|
|
Manufacturer Narrative
|
D4: lot number updated from 0026110442 to 0025497152.D4: expiration date update from 10/01/2022 to 05/07/2022.D4: unique identifier (udi) update from (b)(4).H4: device manufacture date update from 10/01/2020 to 05/07/2020.Device evaluated by mfr.:returned product consisted of the box packaging to an nc emerge balloon catheter.The device returned was an nc emerge balloon catheter along with the matching inner tyvek packaging and shipping hoop.Photo media depicted packaging to both the box and the inner packaging with device.The box shows it was opened as well as the tyvek packaging where the seal on the back was opened to expose the device.The product pouch was visually inspected.The product pouch contained a unit which matched the tyvek packaging batch.The back packaging was torn open prior to being returned.The device was microscopically and visually examined.The device presented no sign of use past removal of packaging.No damage or irregularity to the balloon catheter was found.Inspection of the remainder of the packaging and device presented no damage.Operations engineering personnel reviewed the applicable manufacturing records related to the complaint device.There is no indication that the reported complaint is related to the manufacturing process.Product analysis found the device was not compatible with the box packaging returned at which time it was determined to use an ops memo for this event.Review of photo media provided was found to align with analysis.
|
|
Event Description
|
It was reported that labeling issue occurred.During unpacking of a 2.75mm x 12mm nc emerge balloon, it was noted that a 3.00mm x 12mm nc emerge was found inside the box instead.The procedure was completed and no patient complications were reported.
|
|
Search Alerts/Recalls
|