NIPRO SAFELET IV CATHETER
Report
- Report Number
- 9610987-2023-00003
- Event Type
- Malfunction
- Date Received
- July 25, 2023
- Date of Event
- June 19, 2023
- Report Date
- November 20, 2023
- Manufacturer
- NIPRO CORPORATION (ODT)
- Product Code
- FOZ
- PMA / PMN Number
- K960051
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
FINAL INVESTIGATION REPORT ATTACHED IS ON RETAINED SAMPLES BY THE MANUFACTURER ONLY. MULTIPLE ATTEMPTS MADE TO CUSTOMER TRYING TO OBTAIN ADDITIONAL INFORMATION AND SAMPLES (USED OR UNUSED). NO RESPONSE EVER RECEIVED.
22 GAUGE IV CATHETER CANNULA WHICH WAS INSERTED INTO SAPHENOUS VEIN ON R FOOT BROKE DURING REMOVAL. BREAKAGE OF 3MM DISTAL TIP OF CANNULA ON AN UNSUCCESSFUL IV ATTEMPT, FOUND TIP OF PLASTIC CATHETER BROKEN OFF AND MISSING UPON REMOVAL OF IV. HIGHLY UNUSUAL FOR IT TO BREAK LIKE THIS AFTER USING THOUSANDS OF THE SAME CATHETERS. 3 MM CATHETER TIP SEEN ON FOOT X-RAY PT NEEDING FURTHER IMAGING, WORKUP, EXPLORATION AND SURGICAL REMOVAL
22 GAUGE IV CATHETER CANNULA WHICH WAS INSERTED INTO SAPHENOUS VEIN ON R FOOT BROKE DURING REMOVAL. BREAKAGE OF 3MM DISTAL TIP OF CANNULA ON AN UNSUCCESSFUL IV ATTEMPT, FOUND TIP OF PLASTIC CATHETER BROKEN OFF AND MISSING UPON REMOVAL OF IV. HIGHLY UNUSUAL FOR IT TO BREAK LIKE THIS AFTER USING THOUSANDS OF THE SAME CATHETERS. 3 MM CATHETER TIP SEEN ON FOOT X-RAY PT NEEDING FURTHER IMAGING, WORKUP, EXPLORATION AND SURGICAL REMOVAL
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1813186 | NIPRO SAFELET IV CATHETER | CATHETER | FOZ | NIPRO CORPORATION (ODT) | CI+2225-2C | 22D04C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |