SL CV FOR MAQUET IAB

Description of Event or Problem

IT WAS REPORTED PACKAGE FOUND WITH THE PREP PAD OPEN. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED ON THREE DEVICES. THIS REPORT ADDRESS THE FIRST DEVICE.

Additional Manufacturer Narrative

H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE ANALYSIS, APPLICABLE FMEA DOCUMENTS, APPLICABLE MANUFACTURING RECORDS, AND LABELING. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A PREP PAD LEAK IS CONFIRMED BUT THE EXACT CAUSE REMAINS UNKNOWN. ONE SEALED STATLOCK MAQUET IAB PACKAGE WAS RETURNED FOR EVALUATION. THE PRODUCT INFORMATION INDICATED LOT: JUFQ8517. DISCOLORATION AND EVIDENCE OF DRIED FLUID WAS OBSERVED THROUGH THE CLEAR FILM ON THE PREP PAD PACKAGING. THE FLUID APPEARS TO HAVE LEAKED FROM THE TOP PORTION OF THE PACKAGING SEAL. MICROSCOPIC OBSERVATION OF THE LEAK LOCATION APPEARED TO REVEAL A SLIGHT OPENING IN THE TOP PREP PAD SEAL. THE PREP PAD WAS TORN OPEN IN ORDER TO INSPECT THE COMPONENT AND PACKAGING, AND PREP PAD SOLUTION WAS OBSERVED TO STILL BE PRESENT. EVIDENCE OF A COMPLETE SEAL WAS OBSERVED WHICH SUGGEST THE PACKAGING MAY HAVE BEEN OPENED DUE TO STRESS THAT ACTED ON THE PACKAGE, WHICH FORCED THE SOLUTION THROUGH THE SEAL; HOWEVER, THE ORIGIN OR CAUSE OF THE STRESS COULD NOT BE DETERMINED. SINCE PREP PAD FLUID WAS OBSERVED TO HAVE LEAKED WITHIN A SEALED KIT PACKAGE, THE COMPLAINT IS CONFIRMED BUT THE EXACT CAUSE REMAINS UNKNOWN. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11.

Additional Manufacturer Narrative

THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF JUFQ8517 SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (JUFQ8517) HAVE BEEN REPORTED FROM THE SAME FACILITY.

Description of Event or Problem

IT WAS REPORTED PACKAGE FOUND WITH THE PREP PAD OPEN. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED ON THREE DEVICES. THIS REPORT ADDRESS THE FIRST DEVICE.