BD CATHENA SAFETY IV CATHETER
Report
- Report Number
- 8041187-2023-00177
- Event Type
- Malfunction
- Date Received
- April 26, 2023
- Date of Event
- March 29, 2023
- Report Date
- April 29, 2023
- Manufacturer
- BECTON DICKINSON MEDICAL (SINGAPORE)
- Product Code
- FOZ
- UDI-DI
- 00382903868032
- PMA / PMN Number
- K172506
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 26-APR-2023 INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 1 REPRESENTATIVE SAMPLE FROM BATCH 2110442 SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FLOW RATE SLOW / OCCLUDED WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLE. ANALYSIS OF THE SAMPLE SHOWED THAT THERE WAS NO DAMAGES OR ABNORMALITIES PRESENT. THE SAMPLE WAS FUNCTIONALLY TESTED AND PERFORMED AS DESIGNED WITH NO FAILURES OBSERVED. BD CANNOT DETERMINE A MANUFACTURING RELATED ROOT CAUSE SINCE THE REPORTED DEFECT WAS NOT CONFIRMED DURING THE REPRESENTATIVE SAMPLE EVALUATION. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHILE USING BD CATHENA SAFETY IV CATHETER THERE WAS A BLOCKAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON MARCH 29, RN REPORTED THAT TWICE ON THEIR SHIFT THERE WAS A MALFUNCTION IN THE IV CATHETER. THE CATHETER WAS INSERTED AND BLOOD RETURN FLOW WAS OBSERVED AND NEEDLE WAS REMOVED. ONCE THE CATHETER WAS ATTACHED TO THE IV TUBINGS AND STARTED INFUSION, THERE WAS RESISTANCE. IV WAS DISCONNECTED AND SYRINGE WAS USED IN ATTEMPT TO TEST WHETHER THERE WAS RESISTANCE. IV WAS REMOVED SUBSEQUENTLY AND RESITED. ANOTHER INCIDENT EXPERIENCED BY ANOTHER NURSE WITH A DIFFERENT LOT NUMBER WITH SIMILAR INCIDENT. THE LATTER EVENTUALLY WORKED. ONE OTHER INCIDENT REPORTED BY DR. IN OR. SIMILAR INCIDENT, RESISTANT. IT APPEARS ON ALL THE INCIDENTS THAT THE SPRING MALFUNCTION INSIDE THE IV CATHETER. THE ABOVE INCIDENTS HAPPENED SPORADICALLY USING THE SAME LOT NUMBERS ON MARCH 28 & 29. STORES WAS CONSULTED BUT NO OTHER AVAILABLE LOT NUMBER.
IT WAS REPORTED WHILE USING BD CATHENA SAFETY IV CATHETER THERE WAS A BLOCKAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6), RN REPORTED THAT TWICE ON THEIR SHIFT THERE WAS A MALFUNCTION IN THE IV CATHETER. THE CATHETER WAS INSERTED AND BLOOD RETURN FLOW WAS OBSERVED AND NEEDLE WAS REMOVED. ONCE THE CATHETER WAS ATTACHED TO THE IV TUBINGS AND STARTED INFUSION, THERE WAS RESISTANCE. IV WAS DISCONNECTED AND SYRINGE WAS USED IN ATTEMPT TO TEST WHETHER THERE WAS RESISTANCE. IV WAS REMOVED SUBSEQUENTLY AND RESITED. ANOTHER INCIDENT EXPERIENCED BY ANOTHER NURSE WITH A DIFFERENT LOT NUMBER WITH SIMILAR INCIDENT. THE LATTER EVENTUALLY WORKED. ONE OTHER INCIDENT REPORTED BY DR. IN OR. SIMILAR INCIDENT, RESISTANT. IT APPEARS ON ALL THE INCIDENTS THAT THE SPRING MALFUNCTION INSIDE THE IV CATHETER. THE ABOVE INCIDENTS HAPPENED SPORADICALLY USING THE SAME LOT NUMBERS ON (B)(6). STORES WAS CONSULTED BUT NO OTHER AVAILABLE LOT NUMBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1746701 | BD CATHENA SAFETY IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON MEDICAL (SINGAPORE) | 386803 | 2110442 | 00382903868032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |