Description of Event or Problem · 1
ON 02/02/2000, THE MFR WAS INFORMED BY THE DIST THAT A CUSTOMER (ANOTHER DIST) IN THEIR TERRITORY EXPERIENCED A PROBLEM WITH THE PRODUCT: HOWEVER, THE ONLY INFO AVAILABLE WAS THE CATALOG NUMBER (39809) OF THE DEVICE IN QUESTION. IT WAS ALSO STATED THAT THE DEVICE WAS DEFECTIVE (SPECIFIC NATURE OF DEFECT NOT SPECIFIED). A BLANK PRODUCT COMPLAINT REPORT (PCR) FORM WAS FAXED TO THE DIST SO IT COULD BE FORWARDED TO CUSTOMER FOR COMPLETION. ON 02/07/2000, THE MFR'S REP CONTACTED THE DIST REQUESTING RETURN OF THE COMPLETED PCR FORM AND WAS INFORMED THAT IT HAD NOT BEEN RETURNED. THE DIST WOULD CONTACT THEIR CUSTOMER TO SEE IF IT HAD BEEN COMPLETED AND CONTACT THE MFR'S REP. ON 02/07/2000, THE DIST'S REP INFORMED THE MFR'S REP THAT THE BLANK PCR FORM WAS FORWARDED TO THE FACILITY'S RN FOR COMPLETION AND WOULD BE FAXED TO THE MFR WHEN COMPLETED. ON 02/14/2000, THE MFR'S REP WAS INFORMED BY THE DIST THAT RN HAS TRIED TO CONTACT CUSTOMER, BUT HAS BEEN UNSUCCESSFUL. RN SUGGESTED THAT THE MFR'S REP CALL. ON 02/14/2000, THE MFR WAS INFORMED BY THE DIST'S CUSTOMER THAT THE BLANK PCR FORM WAS FAXED TO THE FACILITY'S OR SUPV FOR COMPLETION AND SUGGESTED THE MFR'S REP CONTACT RN ON 02/14/2000. THE FACILITY'S OR SUPV HAD NO KNOWLEDGE OF THE INCIDENT IN QUESTION AND SUGGESTED THE MFR'S REP SPEAK WITH THE FACILITY'S HEAD NURSE/OR. THE FACILITY'S HEAD NURSE/OR DID NOT KNOW ANYTHING AND HAD FAXED THE PCR FOR BACK TO THE FACILITY'S DIST. NO FURTHER DETAILS WERE PROVIDED.