Midline Catheter Kit P4153108DGRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741140952), received between Oct 22, 2024 and Oct 22, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED LINE FRACTURE AND LEAKING DURING ADMINISTRATION OF OXALIPLATIN AT 12 CM CAUSED LINE TO BE REMOVED. PICC WAS 15 DAYS IN SITU. TRIM LENGTH 50 CM, 8 CM EXTERNAL, 42 CM INTERNAL. INSERTED IN RIGHT BASILIC VEIN. PATIENT REPORTED THAT PICC WAS LEAKING DURING ADMINISTRATION OF OXALIPLATIN. THE LEAK OCCURRED INSIDE THE SKIN OF THE PATIENT WITH INFILTRATION/EXTRAVASATION OF THE FLUID IN THE PATIENT¿S TISSUE AND COMING OUT THROUGH THE EXIT SITE OF THE PICC. PATIENT EXPERIENCED, SWELLING, OEDEMA AND PAIN. (25 % OXALIPLATIN INFUSION HAD BEEN ADMINISTERED WHEN EVENT HAPPENED). EXTRAVASATION OF OXALIPLATIN OCCURRED. PICC WAS REMOVED AND FRACTURE OF THE LINE WAS SEEN AT 12 CM MARK OF THE CATHETER. PATIENT HAD TO GO THROUGH EXTRAVASATION PATHWAY. SWELLING, PAIN, OEDEMA AN TISSUE INJURY OCCURRED. PATIENT COULD NOT COMPLETE HER CHEMOTHERAPY CYCLE WHICH WAS DELAYED. PATIENT WILL NEED A NEW PICC INSERTED TO RESUME THEIR ANTICANCER TREATMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Extravasation; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 20509866 ↗