BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM
Report
- Report Number
- 9610847-2023-00208
- Event Type
- Malfunction
- Date Received
- August 2, 2023
- Date of Event
- January 10, 2023
- Report Date
- September 20, 2023
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- FOZ
- UDI-DI
- 00382903833368
- PMA / PMN Number
- K923702
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 8 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUES OF TUBING DEFECTIVE / DAMAGED AND LEAKAGE WERE NOT CONFIRMED UPON INSPECTION OF THE PHOTOS. WITH THE SUPPLIED PHOTOS IT WAS NOT POSSIBLE TO CLEARLY SEE ANY TUBING DAMAGE OR DEFECTS. BD CANNOT CONFIRM THE CAUSE OF THE FAILURE TO OUR MANUFACTURING PROCESS SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. DHR WAS REVIEWED AND NO QNS OR OTHER EVENTS WERE FOUND RELATED TO THE COMPLAINT STATED BY THE CUSTOMER. ACCORDING TO SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 06-SEP-2023. H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 8 PHOTOS AND 1 SAMPLE SUBMITTED FOR EVALUATION. THE REPORTED ISSUES OF TUBING DEFECTIVE / DAMAGED AND LEAKAGE WERE NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLE PHOTOS AND SAMPLE. ANALYSIS OF THE SAMPLE PHOTOS DID NOT SHOW ANY DAMAGES OR ABNORMALITIES ON THE SAMPLE IN THE PHOTOS. ANALYSIS OF THE PHYSICAL SAMPLE WAS PERFORMED, AND NO DEFECTS OR DAMAGES WERE OBSERVED. THE SAMPLE UNDERWENT LEAKAGE TESTING AND PASSED WITH NO DEFECT OBSERVED. BD COULD NOT DETERMINE A MANUFACTURING RELATED ROOT CAUSE SINCE THE REPORTED DEFECT WAS NOT CONFIRMED DURING THE EVALUATION OF THE SAMPLE. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WAS DAMAGED CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: THERE WAS A HOLE IN DEVICE'S EXTENSION, CAUSING A BLOOD LEAKAGE AFTER PUNCTURE.
IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WAS DAMAGED CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: THERE WAS A HOLE IN DEVICE'S EXTENSION, CAUSING A BLOOD LEAKAGE AFTER PUNCTURE.
IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM WAS DAMAGED CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: THERE WAS A HOLE IN DEVICE'S EXTENSION, CAUSING A BLOOD LEAKAGE AFTER PUNCTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1458350 | BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM | INTRAVASCULAR CATHETER | FOZ | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | 1179659 | 00382903833368 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |