STATLOCK PICC PLUS SLIDING POST
Received Aug 5, 2021 · Event occurred Jul 1, 2021
Report 3006260740-2021-03165 · MDR key 12280634
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Catalog number
VPPCSPCE
Lot number
JUFP8036
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE MANUFACTURER HAS RECEIVED THE SAMPLE AND IS PENDING EVALUATION. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF JUFP8036 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem
IT WAS REPORTED THE PICC LINE HAD COME BACK ABOUT 10CM. IT SEEMS AS IF THE ADHESIVE HAD COME LOOSE FROM THE PATCH CAUSING THE PICC LINE TO COME OUT OF THE VESSEL. TO FIX THE PICC LINE, THE STATLOCK WITH ORDER CODE VPPCSPCE WAS USED. NO OTHER INFORMATION WAS PROVIDED.
Description of Event or Problem
IT WAS REPORTED THE PICC LINE HAD COME BACK ABOUT 10CM. IT SEEMS AS IF THE ADHESIVE HAD COME LOOSE FROM THE PATCH CAUSING THE PICC LINE TO COME OUT OF THE VESSEL. TO FIX THE PICC LINE, THE STATLOCK WITH ORDER CODE VPPCSPCE WAS USED. NO OTHER INFORMATION WAS PROVIDED.
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, COMPLAINT AND LOT HISTORY REVIEW, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE MANUFACTURE RECORDS, AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A DETACHED RETAINER IS CONFIRMED AND APPEARS TO BE MANUFACTURING RELATED. ONE PHOTOGRAPH OF A STATLOCK DEVICE WITH A FOAM PAD WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION OF THE PHOTOGRAPH SHOWED THE RETAINER OF THE STATLOCK DEVICE WAS COMPLETELY DETACHED FROM THE FOAM PAD, WHICH EXHIBITED SOME USE RESIDUE. A HOLE WITH MISSING MATERIAL WAS OBSERVED IN THE LEFT SIDE OF THE FOAM PAD AND A SMALLER PIECE OF THE FOAM PAD APPEARED TO BE MISSING TO THE RIGHT OF THIS HOLE, BUT VERY LITTLE DAMAGE WAS OBSERVED ELSEWHERE ON THE PAD. THE LACK OF ADDITIONAL DAMAGE ON THE FOAM PAD SUGGESTS POOR ADHESIVE COVERAGE ON THE UNDERSIDE OF THE RETAINER. THE INVESTIGATION WAS FORWARDED TO THE MANUFACTURING FACILITY FOR FURTHER EVALUATION, AND BD IS WORKING CLOSELY WITH THE MANUFACTURING FACILITY TO PREVENT RECURRENCE OF THE REPORTED EVENT.