STATLOCK PICC PLUS CRESCENT SLIDING POST

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 HAIR WITHIN THE KIT IS CONFIRMED AND APPEARS TO BE MANUFACTURING RELATED. ONE SEALED STATLOCK PICC PLUS KIT WAS RETURNED FOR EVALUATION. TWO PHOTOS OF A STATLOCK PICC PLUS KIT WERE ALSO PROVIDED FOR EVALUATION. THE PHOTOS CORRESPONDED WITH THE RETURNED PHYSICAL SAMPLE. THE STATLOCK DEVICE, SKIN PREP PAD, AND FOAM STRIP WERE VISIBLE WITHIN THE KIT. A HAIR APPEARED TO BE PRESENT WITHIN THE KIT AND WAS OBSERVED TO BE CAUGHT WITHIN THE SEALING AREA. SINCE THE HAIR WAS FOUND TO BE PRESENT WITHIN THE SEALED KIT PACKAGING, THE COMPLAINT IS CONFIRMED. BD IS WORKING CLOSELY WITH THE MANUFACTURING FACILITY TO PREVENT FURTHER REOCCURRENCE OF THIS EVENT. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11.

Description of Event or Problem

IT WAS REPORTED THE CUSTOMER CLAIMED HAIR FOUND IN PACKAGING. DEVICE WAS NOT USED ON PATIENT. NO OTHER INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE MANUFACTURER HAS RECEIVED THE SAMPLE AND IS PENDING EVALUATION. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF JUFP1026 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED THE CUSTOMER CLAIMED HAIR FOUND IN PACKAGING. DEVICE WAS NOT USED ON PATIENT. NO OTHER INFORMATION WAS PROVIDED.