BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN
Report
- Report Number
- 9610847-2021-00656
- Event Type
- Malfunction
- Date Received
- January 14, 2022
- Date of Event
- December 20, 2021
- Report Date
- February 1, 2022
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- FOZ
- UDI-DI
- 30382903833123
- PMA / PMN Number
- K013800
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE REPORTED LOT # 1062523 WAS NOT FOUND FOR THE REPORTED CATALOG # 383312. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
THE REPORTED LOT # 1062523 WAS NOT FOUND FOR THE REPORTED CATALOG # 383312. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE 1 SAMPLE AND 4 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE WAS CONFIRMED UPON INSPECTION OF THE SAMPLES. THE FOREIGN MATTER FOUND WAS MADE OF SILICONE WHICH IS A PART OF OUR MANUFACTURING PROCESS. HOWEVER, SILICONE IS NOT CONSIDERED A FOREIGN MATTER PARTICULATE BASED OFF OUR MANUFACTURING GUIDELINES. SILICONE IS APPLIED TO THE PRODUCT AS A LUBRICANT IN ORDER TO ASSIST IN THE APPLICATION OF THE DEVICE BY THE END USER. DURING MANUFACTURING SOMETIMES EXCESS SILICONE CAN BUILD UP AT THE CATHETER TIP AND FORM A PARTICULATE THAT CAN BE ASSUMED TO BE FOREIGN MATTER. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.
IT WAS REPORTED 3 BD SAF-T-INTIMA¿ SAFETY SYSTEMS WITH REMOVABLE PRNS HAD FOREIGN MATERIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE WAS FOUND TO HAVE GLUE WHEN UNPACKING IN THE NEPHROLOGY DEPARTMENT".
IT WAS REPORTED 3 BD SAF-T-INTIMA¿ SAFETY SYSTEMS WITH REMOVABLE PRNS HAD FOREIGN MATERIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE WAS FOUND TO HAVE GLUE WHEN UNPACKING IN THE NEPHROLOGY DEPARTMENT".
IT WAS REPORTED 3 BD SAF-T-INTIMA¿ SAFETY SYSTEMS WITH REMOVABLE PRNS HAD FOREIGN MATERIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE WAS FOUND TO HAVE GLUE WHEN UNPACKING IN THE NEPHROLOGY DEPARTMENT".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 626049 | BD SAF-T-INTIMA¿ SAFETY SYSTEM WITH REMOVABLE PRN | INTRAVASCULAR CATHETER | FOZ | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | 383312 | 1062523 | 30382903833123 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |