STATLOCK SLIDING POST TRICOT CRESCENT PAD INCLUDES SKIN PREP
Received Apr 30, 2021 · Event occurred Apr 8, 2021
Report 3006260740-2021-01621 · MDR key 11755564
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Catalog number
PIC0220CE
Lot number
UNKNOWN
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) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.
Description of Event or Problem
IT WAS REPORTED THE CLEAR PART IS BECOMING UNATTACHED FROM THE WHITE SKIN PATCH. 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), LABELING, AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A DETACHED RETAINER IS CONFIRMED; HOWEVER, THE EXACT CAUSE IS UNKNOWN. ONE PHOTOGRAPH OF A PICC PLUS STATLOCK DEVICE WITH A TRICOT PAD AND ADJUSTABLE POSTS WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION OF THE PHOTOGRAPH SHOWED THE RETAINER OF THE DEVICE WAS COMPLETELY DETACHED FROM THE PAD, WHICH WAS ADHERED TO A PATIENT¿S SKIN. SOME USE RESIDUE COULD BE SEEN ON THE SAMPLE IN THE PHOTOGRAPH. A SLIGHT OUTLINE OF WHERE THE RETAINER SHOULD BE LOCATED COULD BE SEEN ON THE PAD. NO DETAIL OF THE UNDERSIDE OF THE RETAINER COULD BE SEEN IN THE RETURNED PHOTOGRAPH. WHILE THE CAUSE OF THE DETACHED RETAINER COULD NOT BE DETERMINED FROM THE RETURNED PHOTOGRAPH, POSSIBLE CAUSES INCLUDE EXPOSURE TO INCOMPATIBLE CHEMICALS, EXCESSIVE PULLING FORCE APPLIED TO THE DEVICE, AND INADEQUATE ADHESION. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11.
Description of Event or Problem
IT WAS REPORTED THE CLEAR PART IS BECOMING UNATTACHED FROM THE WHITE SKIN PATCH. NO OTHER INFORMATION WAS PROVIDED.