MEDEX EXTENSION SETS MULTI LINE
Received Nov 23, 2022 · Event occurred Nov 8, 2022
Report 3012307300-2022-27452 · MDR key 15853702
Device
Generic name
Intravascular Administration Set
Manufacturer
Smiths Medical International, Ltd.Catalog number
MX618CZ
Lot number
4306091
Product problems
- Flushing Problem
- Flushing Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
OTHER TEXT: A CUSTOMER RESPONSE WAS ATTACHED TO THE COMPLAINT. (B5 AND B3)INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
ADDITIONAL INFORMATION WAS RECEIVED: DATE OF THE EVENT: 8TH NOVEMBER 2022. THE LINE WAS GOING TO BE USED ON A PATIENT HOWEVER WE FOUND THE LINE WOULDN'T FLUSH SO IT WAS REMOVED BEFORE USE.
Additional Manufacturer Narrative
PMA/510K IS UNKNOWN, NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT PROBLEM WITH THE CHECK VALVES WHEN TRYING TO FLUSH TWO OF THESE LINES YESTERDAY AND ONLY TWO OF THE LUMENS WERE NOT FLUSHABLE, THE THIRD SET WORKED FINE.
Additional Manufacturer Narrative
OTHER TEXT: H6: HEALTH IMPACT AND EVALUATION CODES: UPDATED. H10: A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. NO PRODUCT SAMPLE NOR PHOTOS WERE RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4).
Additional Manufacturer Narrative
THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). PLEASE DISREGARD THE INITIAL REPORT SUBMITTED WITH THE MFR NUMBER: 3012307300-2022-27452. THE REPORT WAS SUBMITTED IN ERROR., CORRECTED DATA: CORRECTED INFORMATION PROVIDED IN H10.