FDA Adverse Event
Malfunction
Summary report: N
NIPRO SAFELET CATH
MDR report key: 20050503
·
Received August 23, 2024
Report
- Report Number
- 9610987-2024-00006
- Event Type
- Malfunction
- Date Received
- August 23, 2024
- Date of Event
- July 10, 2024
- Report Date
- August 29, 2024
- Manufacturer
- NIPRO CORPORATION (ODT)
- Product Code
- FOZ
- PMA / PMN Number
- K960051
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PICTURE OF ACTUAL USED SAMPLE ATTACHED.
Description of Event or Problem · 0
THE PINPOINT OF IV CATH IS BROKEN IN PUNCTURE OPERATION. THE RESISTANCE OF CATH IS HARDER WHEN PUNCTURING, SO REPEATED PUNCTURE OPERATIONS EXISTED SOMETIMES, AND PINPOINT OF CATH (TIP OF OUTER CATHETER) WAS FOUND BROKEN AFTER WITHDRAWAL. NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATINO PROVIDED.
Description of Event or Problem · 0
THE PINPOINT OF IV CATH IS BROKEN IN PUNCTURE OPERATION. THE RESISTANCE OF CATH IS HARDER WHEN PUNCTURING, SO REPEATED PUNCTURE OPERATIONS EXISTED SOMETIMES, AND PINPOINT OF CATH (TIP OF OUTER CATHETER) WAS FOUND BROKEN AFTER WITHDRAWAL. NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATINO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1743061 | NIPRO SAFELET CATH | IV CATHETER | FOZ | NIPRO CORPORATION (ODT) | NIC-22G (1") | 24A18C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |