DHR WAS OBTAINED AND REVIEWED. ALL IN-PROCESS TESTS AN D INSPECTIONS COMPLETED. NO UNTOWARD RESULTS NOTED. PACKAGING FORM FOR LABELS AND RECONCILIATION WAS REVIEWED NO ISSUES NOTED. RECORD OF INSPECTION DURING SECONDARY PACKAGING FORM WAS REVIEWED. SAMPLE SIZE OF 200 POUCHES INSPECTED, ALL RESULTS PASSED INSPECTION. MULTIVAC IN-PROCESS TEST FORM WAS REVIEWED, VISUAL INSPECTION RESULTS ALL PASSED, SEAL STRENGTH RESULTS WITHIN SPECIFICATION. NO OTHER UNTOWARD ISSUES WERE ASSOCIATED WITH THIS LOT. ALL OPERATORS FOR THIS PROCESS HAVE BEEN NOTIFIED OF THE ISSUE AND SHOWN PICTURES OF THE DEFECTIVE POUCHED NEEDLES TO MAKE THEM AWARE THE EVENT OCCURRED.
D
Patient 1
CUSTOMER NARRATIVE IS AS FOLLOWS: 'I DO RECEIVE A FEEDBACK FROM OUR CUSTOMER FROM (B)(6) LAST FRIDAY THAT ONE BOX OF TECA ELITE NEEDLE THEY RECEIVED GOT A FEW PACKS OF DCN NEEDLE (NEW AND SEALED) WHEREBY THE NEEDLE CAP IS FALLING APART FROM THE NEEDLE. THEY MENTIONED TO ME THIS MAY CAUSE SHARP INJURY TO THE NEUROLOGIST OR NEURO TECHNOLOGIST WHO IS HELPING TO PREPARE THE EMG STUDIES. THEY SAID THIS KIND OF INCIDENT SHOULDN'T HAPPEN.'
N
Patient 1
THE FOLLOWING HAS BEEN CORRECTED (FROM INITIAL REPORT): IF FOLLOW-UP, WHAT TYPE? - AS THE REPORT THAT WAS PREVIOUSLY SUBMITTED WAS AN INITIAL REPORT, THE FIELD SHOULD HAVE BEEN EMPTY. CHANGED FROM ''DEVICE EVALUATION'' TO AN EMPTY FIELD JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: SERIAL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE SERIAL #. IF IMPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. IF EXPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. REPROCESSOR NAME AND ADDRESS - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT. IF IND, GIVE PROTOCOL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. ADVERSE EVENT TERM(S) - THIS SECTION IS NOT APPLICABLE TO MEDICAL DEVICES. (B)(4). IF REMEDIAL ACTION INITIATED, CHECK TYPE - THIS SECTION IS NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED. IF ACTION REPORTED TO FDA UNDER 21 USC 360I(F), LIST CORRECTION/REMOVAL REPORTING NUMBER - THIS SECTION IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21 USC 360I(F) CUSTOMER HAS BEEN CONTACTED TO PROVIDE THE REST OF THE REQUIRED INFORMATION. WE ARE IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION. A LETTER LISTING OUTSTANDING INFORMATION HAS BEEN SENT TO CUSTOMER TO OBTAIN ADDITIONAL INFORMATION IN ORDER TO SUBMIT FOLLOW UP REPORT AND/OR EXPLAIN WHY REQUIRED INFORMATION WAS NOT PROVIDED AND STEPS TAKEN TO OBTAIN SUCH INFORMATION. THE FOLLOWING STILL REQUIRE INFORMATION: PATIENT IDENTIFIER - AWAITING CUSTOMER RESPONSE. AGE AT THE TIME OF EVENT, DATE OF BIRTH - AWAITING CUSTOMER RESPONSE. SEX - AWAITING CUSTOMER RESPONSE. WEIGHT - AWAITING CUSTOMER RESPONSE. OUTCOMES ATTRIBUTED TO ADVERSE EVENT - AWAITING CUSTOMER RESPONSE. RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES - AWAITING CUSTOMER RESPONSE. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS (E.G., ALLERGIES, RACE, PREGNANCY, SMOKING AND ALCOHOL USE, HEPATIC/RENAL DYSFUNCTION, ETC.) - AWAITING CUSTOMER RESPONSE. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDES TREATMENT OF EVENT) - AWAITING CUSTOMER RESPONSE. (B)(4).