MEDEX MICRO BORE EXTENSION SETS
Received Feb 17, 2022
Report 3012307300-2022-03547 · MDR key 13549589
Device
Generic name
Filter, Infusion Line
Manufacturer
Smiths Medical Asd, Inc.Model number
FS116Catalog number
FS116
Lot number
4068818
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PICU HAS HAD "7-8+" OCCURRENCES OF CRACKED/LEAKING FILTERS FROM THE SAME LOT, SO 9 FILES CREATED. NO PATIENT INJURY WAS REPORTED.
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. IT WAS OBSERVED THAT THE FILTER IS OPEN IN ONE SIDE WHERE SHOULD BE WELDED. IT PRESENT DAMAGED WHICH MAY INDICATE A WRONG HANDLING OF THE PART. 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. SUPPLIER NOTIFICATION WAS ISSUED ON (B)(6) 2021 TO SUPPLIER (B)(4).
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. IT WAS OBSERVED THAT THE FILTER IS OPEN IN ONE SIDE WHERE SHOULD BE WELDED. IT PRESENT DAMAGED WHICH MAY INDICATE A WRONG HANDLING OF THE PART. 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. SUPPLIER NOTIFICATION WAS ISSUED ON (B)(6) 2021 TO SUPPLIER (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT THE PICU HAS HAD "7-8+" OCCURRENCES OF CRACKED/LEAKING FILTERS FROM THE SAME LOT, SO 9 FILES CREATED. NO PATIENT INJURY WAS REPORTED.