inforMED
MalfunctionMAL

HEMASHIELD PLATINIUM WOVN DOUBLE VELOUR

Received Nov 8, 2019 · Event occurred Oct 7, 2019

Report 1640201-2019-00082 · MDR key 9294936

Device

Generic name

Graft, Vascular, Synthetic/biologic Composite

Manufacturer

Intervascular Sas

Model number

M00202175208P0

Catalog number

M00202175208P0

Lot number

19H28

Product problems

  • Manufacturing, Packaging or Shipping Problem
  • Manufacturing, Packaging or Shipping Problem

Patient

Not reported

  • No Patient Involvement
  • No Patient Involvement

Narrative

Additional Manufacturer Narrative

(B)(4). THE INVOLVED PRODUCT WAS RETURNED TO INTERVASCULAR AND WAS INSPECTED BY OUR QUALITY ASSURANCE (QA) SUPERVISOR FOR AN EVALUATION OF THE DAMAGE EXTENT. HIS OBSERVATIONS ARE AS FOLLOWS: "THE OUTER PACKAGING WAS NOT OPENED, THE OUTER PACKAGING IS DAMAGED BUT THERE IS NO VISIBLE MOISTURE (THE CARDBOARD IS NOT CURLED, NO INK), THE INNER PACKAGING IS NEITHER OPENED NOR DAMAGED." THE INVESTIGATION IS ONGOING. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

THE CUSTOMER HAS RECEIVED THE WET PARCEL AND HE CAN'T ACCEPT IT.

Additional Manufacturer Narrative

(10/4246) FOLLOWING THE INSPECTION OF THE QUALITY ASSURANCE (QA) SUPERVISOR, A NON-CONFORMITY REPORT WAS OPENED. AFTER INVESTIGATION THE CONCLUSION IS THAT THE EVENT IS DUE TO A LOGISTIC ISSUE. (4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME LOT NUMBER. (4308) THE MOST LIKELY CAUSE OF THIS EVENT IS AN INAPPROPRIATE HANDLING OF THE PRODUCT DURING TRANSPORT BY OUR LOGISTIC SUBCONTRACTOR. THE ROOT CAUSE REMAINS UNKNOWN. AN INFORMATION ABOUT THIS DISCREPANCY HAD BEEN SENT TO OUR LOGISTIC SUBCONTRACTOR.

Description of Event or Problem

SEE INITIAL REPORT.