MEDEX MICRO BORE EXTENSION SETS
Received Feb 14, 2022 · Event occurred Apr 10, 2021
Report 3012307300-2022-03344 · MDR key 13528450
Device
Generic name
Filter, Infusion Line
Manufacturer
Smiths Medical Asd, Inc.Model number
FS116Catalog number
FS116
Lot number
4068818
Product problems
- Defective Component
- Defective Component
Patient
1 MO · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO SMITHS MEDICAL. A SAMPLE WAS TEST FOR LEAKAGE BY MANUALLY INTRODUCING WATER USING A SYRINGE. THE SAMPLE PRESENT LEAKAGE BY ONE OF THE SIDE OF THE FILTER. DHR REVIEW WAS EXECUTED AND NO DISCREPANCIES WERE OBSERVED DURING THE MANUFACTURING OF REPORTS LOT 4068818. THE LOT USED OF FILTER P1123-07 WAS 6447/20, NO DEFECTS WERE REPORTED ON THIS LOT OF FILTER. COMPLAINT IS CONFIRMED DUE TO SAMPLE RETURN PRESENT LEAKAGE AT FILTER, HOWEVER ROOT CAUSE IS NOT ATTRIBUTABLE TO MANUFACTURING. LOT 4068818 FROM PN: FS116 WAS MANUFACTURED ON SMITHS MEDICAL MMON SITE ON (B)(6) 2020 PER (B)(4) PIECES. NO DISCREPANCIES WERE OBSERVED DURING THE MANUFACTURING OF THIS LOT.
Description of Event or Problem
IT WAS REPORTED THAT THE PICU HAS HAD "7-8+" OCCURRENCES FROM THE SAME LOT, SO 9 FILES CREATED. CRACKED/LEAKING FILTERS. NO PATIENT INJURY WAS REPORTED.