NIPRO SAFELET CATH CI+2225Recalls & reported problems
Nipro Medical Corporation · Intravascular catheter · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10383790006405), received between Nov 25, 2019 and Aug 11, 2021 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Break3
- Material Fragmentation1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2021Break; Break
DATE OF OCCURRENCE IS UNKNOWN: CUSTOMER REPORTED 2 INCIDENTS WHERE THE CATHETER BROKE UPON INSERTION TO THE PATIENT. NO INJURIES, MEDICAL INTERVENTIONS OR HOSPITALIZATION. AFTER OPENING 1 BOX, SEVERAL CATHETERS WERE FOUND WITH THE CLEAR AND BLUE OUTER CASING BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12309543 ↗MalfunctionAug 11, 2021Break; Break
DATE OF OCCURRENCE IS UNKNOWN: CUSTOMER REPORTED 2 INCIDENTS WHERE THE CATHETER BROKE UPON INSERTION TO THE PATIENT. NO INJURIES, MEDICAL INTERVENTIONS OR HOSPITALIZATION. AFTER OPENING 1 BOX, SEVERAL CATHETERS WERE FOUND WITH THE CLEAR AND BLUE OUTER CASING BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12309402 ↗MalfunctionNov 25, 2019Material Fragmentation; Material Fragmentation
DURING A SPAY PROCEDURE OF A DOG, THE CLINIC TECHNICIAN HAD A HARD TIME PLACING THE IV CATHETER INSIDE THE VEIN. WHEN THE CATHETER WAS PULLED OUT OF THE DOG'S SKIN, IT BECAME STUCK. WHEN THE TECHNICIAN PULLED OUT THE CATHETER, ABOUT 5MM OF THE CATHETER TIP BROKE OFF AND REMAINED IN THE DOG'S SKIN. THE BROKEN PIECE HAD TO BE SURGICALLY REMOVED. PER THE CLINIC STAFF, THE DOG IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 9369650 ↗InjuryNov 25, 2019Break; Physical Resistance/Sticking
DURING A SPAY PROCEDURE OF A DOG, THE CLINIC TECHNICIAN HAD A HARD TIME PLACING THE IV CATHETER INSIDE THE VEIN. WHEN THE CATHETER WAS PULLED OUT OF THE DOG'S SKIN, IT BECAME STUCK. WHEN THE TECHNICIAN PULLED OUT THE CATHETER, ABOUT 5MM OF THE CATHETER TIP BROKE OFF AND REMAINED IN THE DOG'S SKIN. THE BROKEN PIECE HAD TO BE SURGICALLY REMOVED. PER THE CLINIC STAFF, THE DOG IS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9369399 ↗
Other Catheter,intravascular,therapeutic,short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page