SL CV FOR MAQUET IAB

Additional Manufacturer Narrative

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 FOREIGN MATERIAL WITHIN THE KIT IS CONFIRMED AND APPEARS TO BE MANUFACTURING RELATED. THREE SEALED STATLOCK MAQUET IAB PACKAGES WERE RETURNED FOR EVALUATION. TWO PHOTOS OF THE STATLOCKS PACKAGES WERE ALSO RETURNED FOR EVALUATION. THE PHOTOS CONTAIN THREE PACKAGES WHICH CORRESPOND WHICH THE CONDITIONS OF THE RETURNED SAMPLES. THE PRODUCT INFORMATION INDICATED LOT: JUFQ8517. TWO KITS WERE OBSERVED TO CONTAIN A HARD, PLASTIC MATERIAL. THE MATERIAL WAS OBSERVED TO BE A BRITTLE PLASTIC WHEN TOUCHED. THE THIRD SEALED KIT WAS OBSERVED TO CONTAIN A HAIR. SINCE THE HAIR AND PLASTIC WERE FOUND TO BE PRESENT WITHIN A SEALED KIT, THE COMPLAINT IS CONFIRMED. BD IS WORKING CLOSELY WITH THE MANUFACTURING FACILITY TO PREVENT RECURRENCE OF THE REPORTED EVENT. 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 A PACKAGE WITH FOREIGN MATTER IN THE POUCH. NO OTHER INFORMATION WAS PROVIDED. THREE DEVICE SAMPLES WERE RETURNED. THIS REPORT ADDRESSES THE SECOND DEVICE.