inforMED
MalfunctionFOX

STATLOCK SLIDING POST TRICOT CRESCENT PAD INCLUDES SKIN PREP

Received Apr 9, 2021 · Event occurred Mar 19, 2021

Report 3006260740-2021-01272 · MDR key 11645282

Device

Generic name

Stand, Infusion

Catalog number

PIC0220CE

Lot number

JUDY2496

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

Description of Event or Problem

IT WAS REPORTED THE STATLOCK RETAINER DETACHED. 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 DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. H3 OTHER TEXT : DEVICE NOT RETURNED FOR EVALUATION.

Additional Manufacturer Narrative

THE MANUFACTURER HAS RECEIVED THE SAMPLE AND IS PENDING EVALUATION. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF JUDY2496 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem

IT WAS REPORTED THE STATLOCK RETAINER DETACHED. NO OTHER INFORMATION WAS PROVIDED.