8MM 30CM HEMASHIELD FLAT WDV
Received Mar 5, 2014 · Event occurred Feb 9, 2014
Report 2242352-2014-00273 · MDR key 3703796
Device
Generic name
Vascular Graft
Manufacturer
Maquet Cardiovascular, LlcModel number
M00202175208P0Catalog number
NA
Lot number
25064436
Product problems
- Fluid/Blood Leak
Patient
NI
- Blood Loss
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO THE FACTORY FOR EVAL. IT SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. A VISUAL INSPECTION DID NOT IDENTIFY ANY NONCONFORMITIES WITH THE DEVICE. WHILE WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT, ALL OF THE GRAFT MANUFACTURED WITHIN THE REPORTED BATCH PASSED NON-DESTRUCTIVE PERMEABILITY TESTING, PER PRODUCT SPECIFICATION. IN ADDITION, A REP SAMPLE UNDERWENT WATER POROSITY TESTING AND WAS FOUND TO BE WELL WITHIN PRODUCT SPECIFICATIONS. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).
Description of Event or Problem
THE HOSPITAL REPORTED THAT A NOTE WAS OBSERVED ON THE BOX OF A 8MM 30CM HEMASHIELD PLAT WDV STATING "RIGHT AXILLARY 500ML BLOOD LOSS." THE SURGEON STATED THAT THE GRAFT "SWEATED" A LITTLE MORE THAN USUAL. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS NOT NOTED IF THE PT WAS GIVEN A TRANSFUSION. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.