BD SMARTSITE¿ EXTENSION SET, LOW SORBING, 0.2 MICRON FILTER
Received Jan 4, 2023 · Event occurred Dec 15, 2022
Report 9616066-2022-02121 · MDR key 16096426
Device
Generic name
Intravascular Administration Set
Manufacturer
Sistemas Medicos Alaris, S.a. De C.v.Model number
20350ECatalog number
20350E
Lot number
UNKNOWN
Product problems
- Air/Gas in Device
- Air/Gas in Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H6: INVESTIGATION SUMMARY NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. IT WAS REPORTED THAT AIR WAS FOUND IN A PATIENT¿S LINE POSSIBLY RESULTING FROM A NEWLY PRIMED ADD-ON FILTER. THE CUSTOMER COMPLAINT COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 20350E BECAUSE A LOT NUMBER IS UNKNOWN. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD SMARTSITE¿ EXTENSION SET, LOW SORBING, 0.2 MICRON FILTER AIR ENTERED THE LINE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AN EVENT WAS REPORTED WHERE AIR WAS FOUND IN A PATIENT¿S LINE POSSIBLY RESULTING FROM A NEWLY PRIMED ADD-ON FILTER.
Additional Manufacturer Narrative
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED WHILE USING BD SMARTSITE¿ EXTENSION SET, LOW SORBING, 0.2 MICRON FILTER AIR ENTERED THE LINE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AN EVENT WAS REPORTED WHERE AIR WAS FOUND IN A PATIENT¿S LINE POSSIBLY RESULTING FROM A NEWLY PRIMED ADD-ON FILTER.