EDWARDS LIFESCIENCES EDWARDS PERICARDIAL PATCH; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
|
Back to Search Results |
|
Model Number 4700 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/30/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
|
|
Event Description
|
It was reported that, upon receipt, two (2) 4700 bovine pericardial patches were found to be leaking within the shipping box.There was no physical damage to the shipping box but the shelf boxes were found to be wet and discolored.
|
|
Manufacturer Narrative
|
H10: additional manufacturer narrative: h3: evaluation summary: customer report of solution leakage and damaged shelf box were confirmed.The device was received in its original packaging with damaged top paneling; patch jar was still sealed within its shrink wrapping.The jar was observed to have multiple cracks on the bottom of the jar with a crack extended on the side of the jar.At the bottom of the jar four cracks measured 18mm, 27mm, 20mm, 23mm.The fourth crack ran lengthwise on the side of the jar by approximately 110mm.The patch remained inside of the jar.There were no glutaraldehyde solution in the jar.Yellow stains were apparent at multiple locations on the shelf box.The patch had a few creases and was dehydrated.Tagalert was not returned.Engineering task will be opened for further investigation.
|
|
Manufacturer Narrative
|
The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.Damage to the package/product is most likely the result of mechanical damage incurred while in the care of the customer or in transit from the courier, and not an indication of a device malfunction.There is no allegation of a device malfunction and there is no device failure.
|
|
Search Alerts/Recalls
|
|
|