BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER
Report
- Report Number
- 8041187-2022-00070
- Event Type
- Malfunction
- Date Received
- February 7, 2022
- Date of Event
- January 24, 2022
- Report Date
- March 29, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL (SINGAPORE)
- Product Code
- FOZ
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. 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 CORRECTED INFORMATION: H.6. IMDRF ANNEX A GRID: A0504 - LEAK / SPLASH THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 03-MAR-2022. H.6. INVESTIGATION: TWO SAMPLES AND ONE PHOTO WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, A 22G VENFLON PRO SAFETY PRODUCT WITH BLOOD LEAKAGE FROM THE END CAP WAS OBSERVED. A REPRESENTATIVE SAMPLE FROM BATCH 1140524 WAS RECEIVED. THE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION. THE SAMPLE PASSED THE ACCEPTANCE CRITERIA, AND NO ABNORMALITIES WERE OBSERVED. THE END CAP BELONGS TO CAVITY #21. NO HOLE WAS OBSERVED ON THE END CAP LUER CONE TIP. ONE USED (CONTAMINATED) END CAP WITH CAVITY #49 WAS ALSO RECEIVED. THE USED END CAP WAS SUBJECTED TO VISUAL INSPECTION. A SINK MARK WAS OBSERVED ON THE END CAP AND A THROUGH HOLE WAS OBSERVED ON THE LUER CONE TIP. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE END CAP BATCH USAGE RECORD, FOR THE REPORTED BATCH 1140524, CAVITY #49 WAS NOT USED IN THE PRODUCTION OF THIS ASSEMBLED BATCH. CAVITY #49 COULD BE A SAMPLE FROM THE SAME CUSTOMER OF ANOTHER ASSEMBLY BATCH. THE PROBABLE ROOT CAUSE FOR THE REPORTED LEAKAGE COULD BE DUE TO THE SINK MARK HOLE AT THE LUER CONE TIP OF THE END CAP. THE AIR VENT MAY BE CHOKED DURING MOLDING AND CAUSE HOT AIR TO BE TRAPPED. THIS AFFECTS THE MATERIAL FLOW TO THE FINAL FILL AREA AT THE LUER CONE TIP. A PROJECT, CAPA#4710247, HAS BEEN INITIATED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT BLOOD LEAKED FROM A HOLE IN THE BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT" DRIPS OUT OF THE HOLE IN THE FILLET "ON VENFLON. WHEN VENFLON IS PLACED AND YOU PUT THE WHITE PLUG ON VENFLON (THE ONE THAT COMES WITH THE SET) THEN THE BLOOD RUNS BACK AND OUT ALONG THE HOLE. THERE SHOULD USUALLY BE A FILTER STOPPING IT. HAVE EXPERIENCED WITH SEVERAL ITEMS FROM THIS LOT."
IT WAS REPORTED THAT BLOOD LEAKED FROM A HOLE IN THE BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT" DRIPS OUT OF THE HOLE IN THE FILLET "ON VENFLON. WHEN VENFLON IS PLACED AND YOU PUT THE WHITE PLUG ON VENFLON (THE ONE THAT COMES WITH THE SET) THEN THE BLOOD RUNS BACK AND OUT ALONG THE HOLE. THERE SHOULD USUALLY BE A FILTER STOPPING IT. HAVE EXPERIENCED WITH SEVERAL ITEMS FROM THIS LOT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 974631 | BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON MEDICAL (SINGAPORE) | 1140524 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |