BD SMARTSITE¿ EXTENSION SET, LOW SORBING, 0.2 MICRON FILTER
Received Jun 9, 2023 · Event occurred May 18, 2023
Report 9616066-2023-01139 · MDR key 17095596
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
- Defective Component
- Defective Component
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
IT WAS REPORTED WHILE USING BD SMARTSITE¿ EXTENSION SET, LOW SORBING, 0.2 MICRON FILTER THE TUBING WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REACHED OUT THROUGH CHAT STATING THE MICRON FILTER TUBING FLATTENS AFTER THE FILTER SECTION, AND WANTS TO KNOW IF THAT IS NORMAL.
Additional Manufacturer Narrative
H6: INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF TUBING DEFECTIVE/DAMAGED COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE 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 THE TUBING WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REACHED OUT THROUGH CHAT STATING THE MICRON FILTER TUBING FLATTENS AFTER THE FILTER SECTION, AND WANTS TO KNOW IF THAT IS NORMAL.
Additional Manufacturer Narrative
B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H.4. DEVICE MANUFACTURE DATE: UNKNOWN H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.