STATLOCK PICC PLUS CRESENT SLIDING POST BULK KIT

Additional Manufacturer Narrative

THE MANUFACTURER HAS RECEIVED THE SAMPLE AND IS PENDING EVALUATION. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF JUDZ0386 SHOWED TEN OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem

PER TM, THE UNIT SIT WAS REPORTED BY TM "FACILITY REPORTED AN ISSUE WITH A BIOSTABLE PICC W/PASV. IT WAS REPORTED THAT THE PICC IS NORMALLY FIXATED WITH THE STATLOCK; HOWEVER, FOR THE PAST FEW MONTHS, THIS FACILITY HAS BEEN NEEDING TO REPLACE PICCS BECAUSE THE FIRST PICCS PLACED HAVE COME OUT DUE TO THE BAD FIXATION OF THE STATLOCK DEVICE, AT THE SKIN. IT WAS ALSO NOTED THAT THE CASE COMES OFF FROM THE ADHESIVE PLASTER, VERY EASILY. THE CUSTOMER STATED THEY NOTICED A CHANGE IN STATLOCK FROM A FOAM PAD MATERIAL TO A CANVAS CLOTH TAPE MATERIAL. THE CANVAS CLOTH TAPE MATERIAL HAS HAD ISSUES OF NOT STICKING TO SKIN RESULTING IN PICC MALPOSITION." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES LOT #JUDZ0386.

Description of Event or Problem

PER TM, THE UNIT SIT WAS REPORTED BY TM "FACILITY REPORTED AN ISSUE WITH A BIOSTABLE PICC W/PASV. IT WAS REPORTED THAT THE PICC IS NORMALLY FIXATED WITH THE STATLOCK; HOWEVER, FOR THE PAST FEW MONTHS, THIS FACILITY HAS BEEN NEEDING TO REPLACE PICC¿S BECAUSE THE FIRST PICC¿S PLACED HAVE COME OUT DUE TO THE BAD FIXATION OF THE STATLOCK DEVICE, AT THE SKIN. IT WAS ALSO NOTED THAT THE CASE COMES OFF FROM THE ADHESIVE PLASTER, VERY EASILY. THE CUSTOMER STATED THEY NOTICED A CHANGE IN STATLOCK FROM A FOAM PAD MATERIAL TO A ¿CANVAS¿ CLOTH TAPE MATERIAL. THE CANVAS CLOTH TAPE MATERIAL HAS HAD ISSUES OF NOT STICKING TO SKIN RESULTING IN PICC MALPOSITION." NO OTHER INFORMATION WAS PROVIDED. THIS REPORT ADDRESSES LOT #JUDZ0386.

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, PHOTO ANALYSIS, APPLICABLE FMEA DOCUMENTS, APPLICABLE MANUFACTURING RECORDS, AND LABELING. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF DIFFICULTY RETAINING CATHETER LINES WITH THE PICC PLUS CRESCENT STATLOCK DEVICE WAS CONFIRMED BUT THE CAUSE IS UNKNOWN. A PHOTO OF TWO STATLOCK DEVICES WAS RETURNED FOR EVALUATION OF THIS EVENT. BOTH STATLOCK DEVICES APPEARED UNUSED AS THE ADHESIVE BACKING STRIPS WERE STILL ON THE DEVICES. ONE OF THE DEVICES WAS A TRICOT PAD (WHICH IS LIKELY WHAT IS BEING REFERRED TO AS CANVAS BY THE COMPLAINANT) AND THE OTHER CONTAINS A FOAM PAD. IT WAS VERIFIED THAT THE PRODUCT CODE SUPPLIED IN THE COMPLAINT FILE CORRESPONDED WITH A TRICOT PAD. THE FOAM PAD STATLOCK DEVICE APPEARED UNREMARKABLE IN THE PHOTO. THE TRICOT STATLOCK PRODUCT HAD A PARTIALLY DETACHED RETAINER. ONE OF THE SLIDING RETAINING POSTS HAD MOVED FROM THE GROOVE IN THE RETAINER AND LOOKED LOOSE BETWEEN THE RETAINER AND THE TRICOT PAD. POTENTIAL CAUSES OF THE RETAINER NOT ADHERING TO THE PAD COULD INCLUDE AGGRESSIVE HANDLING OF THE DEVICE (E.G. PULLING) OR THE JOINT BEING WEAKENED BY AN ANTISEPTIC OR CLEANING AID. THE COMPLAINANT ALSO STATED THAT THERE HAS BEEN BAD FIXATION AT THE SKIN. HOWEVER, THIS FAILURE MODE CANNOT BE ASSESSED FROM A PHOTO SAMPLE. POTENTIAL CAUSES OF THE PAD NOT ADHERING TO PATIENT INCLUDE IMPROPER ADHESIVE/MATERIALS, IMPROPER PREPARATION OF SITE (E.G. NOT ALLOWED TO FULLY DRY BEFORE STATLOCK APPLICATION), CHEMICAL INCOMPATIBILITY WITH A CLEANING CHEMICAL, OR TENSILE (PULLING) FORCES APPLIED TO THE DEVICE. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11.