inforMED
MalfunctionMEF

MAM

Received Feb 6, 2004 · Event occurred Dec 1, 2003

Report 524749 · MDR key 524749

Device

Generic name

Infant Pacifier

Model number

521 STERILE

Catalog number

521

Lot number

11Z2

Product problems

  • Sterility
  • Tear, Rip or Hole in Device Packaging

Patient

*

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

THIS DEFECT WAS RECOGNIZED PRIOR TO DELIVERY TO THE PT AREA. STERILE PACKAGING HAD BEEN PERFORATED ON 41 INDIVIDUAL PACKAGES. USER IS CONFIDENT THAT THE PRODUCT HAS COME IN FROM MFR IN THIS CONDITION. THE PACKAGING OF EACH OF THE 41 UNITS HAD BEEN PERFORATED; MOST APPEARED TO HAVE BEEN SLICED - AS IF BY A KNIFE. USER SUSPECTS - BUT DOSE NOT KNOW - THAT THIS HAPPENED IN THE MFR'S PACKAGING PROCESS. CO HAS NOTIFIED THE MFR. USER WILL SHIP THE DEFECTIVE PRODUCT TO THE MFR - PROBABLY ON 12/2003.