BD CATHENA¿ SAFETY IV CATHETER
Report
- Report Number
- 8041187-2022-00347
- Event Type
- Malfunction
- Date Received
- July 7, 2022
- Date of Event
- June 8, 2022
- Report Date
- October 10, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL (SINGAPORE)
- Product Code
- FOZ
- UDI-DI
- 00382903868605
- PMA / PMN Number
- K220584
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 10-AUG-2022. H.6. INVESTIGATION SUMMARY: ONE PHOTO AND ONE SAMPLE WITH OPEN PACKAGING WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, THE SAFETY MECHANISM WAS OBSERVED TO NOT BE ACTIVATED. THE SAMPLE WAS OBSERVED WITH THE SAFETY MECHANISM NOT ACTIVATED. THE TIP SHIELD WAS MANUALLY PUSHED THROUGH THE CANNULA AND WAS ABLE TO BE ACTIVATED PROPERLY; NO SAFETY ACTIVATION FAILURE WAS OBSERVED. NO DENT WAS OBSERVED ON THE CANNULA. A DEVICE HISTORY RECORD REVIEW FOUND NO ABNORMALITIES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE EVALUATION ON THE RETURNED SAMPLE, NO DENT WAS OBSERVED ON THE CANNULA THAT WOULD OBSTRUCT THE MOVEMENT OF THE TIP SHIELD FOR SAFETY ACTIVATION. THE SAFETY MECHANISM OF THE RETURNED SAMPLE WAS ABLE TO BE MANUALLY ACTIVATED AND NO SAFETY ACTIVATION FAILURE WAS OBSERVED. THEREFORE, THE ROOT CAUSE COULD NOT BE ESTABLISHED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.
CORRECTION: G.5. PMA / 510(K)#: K220584 H6: INVESTIGATION SUMMARY ONE PHOTO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, THE SAFETY MECHANISM WAS OBSERVED TO NOT BE ACTIVATED. A DEVICE HISTORY RECORD REVIEW FOUND NO ABNORMALITIES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. FROM THE PHOTO, THE SAFETY MECHANISM WAS NOT ACTIVATED, HOWEVER, THE TEAM IS UNABLE TO EVALUATE FROM THE PHOTO WHETHER THERE IS SAFETY ACTIVATION COMPONENTS FAILURE OR DAMAGE THAT COULD HAVE RESULTED IN THE SAFETY ACTIVATION FAILURE. AS NO SAMPLE WAS RETURNED, A ROOT CAUSE COULD NOT BE ESTABLISHED.
IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER EXPERIENCED A SAFETY MECHANISM THAT WOULD NOT ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CATHENA WAS NOT ABLE TO SAFETY."
IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER EXPERIENCED A SAFETY MECHANISM THAT WOULD NOT ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CATHENA WAS NOT ABLE TO SAFETY."
IT WAS REPORTED THAT THE BD CATHENA¿ SAFETY IV CATHETER EXPERIENCED A SAFETY MECHANISM THAT WOULD NOT ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CATHENA WAS NOT ABLE TO SAFETY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2867125 | BD CATHENA¿ SAFETY IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON MEDICAL (SINGAPORE) | 386860 | 1175157 | 00382903868605 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |