Hickman 0601630Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741036408), received between Jan 31, 2019 and Apr 6, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

1. Jan 4, 2023Open, Classified

   Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).

   Z-1051-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2022Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS DAMAGED AND LEAKAGE OCCURRED NEAR THE CATHETER HUB. THE DAMAGED OF CATHETER WAS REPAIRED USING A REPAIR KIT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021185 ↗
• MalfunctionAug 10, 2021Fracture; Fracture

  IT WAS REPORTED THAT SOME TIME POST CATHETER PLACEMENT FOR EPOPROSTENOL HOME CONTINUOUS IV THERAPY, THE CATHETER WAS ALLEGEDLY DAMAGED NEAR THE HUB. IT WAS FURTHER REPORTED THAT THE CATHETER WAS CLAMPED NEAR THE CLAMPING OVER SLEEVE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300542 ↗
• MalfunctionAug 10, 2021Fracture; Fracture

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY DAMAGED NEAR THE HUB. IT WAS FURTHER REPORTED THAT THE CATHETER WAS CLAMPED NEAR THE CLAMPING OVER SLEEVE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300463 ↗
• MalfunctionAug 10, 2021Fracture; Fracture

  IT WAS REPORTED THAT ONE MONTH POST CATHETER PLACEMENT, THE CATHETER WAS ALLEGEDLY DAMAGED NEAR THE HUB. IT WAS FURTHER REPORTED THAT THE CATHETER WAS CLAMPED NEAR THE CLAMPING OVER SLEEVE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300462 ↗
• MalfunctionJun 24, 2021Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT SOME TIME POST CATHETER IMPLANT, THE CATHETER WAS ALLEGEDLY DAMAGED NEAR THE CATHETER HUB. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12055980 ↗
• MalfunctionMar 25, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE, THE KIT DOES NOT INCLUDE A SILICONE ADHESIVE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11566990 ↗
• MalfunctionOct 17, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0601630 PORT & CATHETER ALLEGEDLY EXPERIENCED A FLUID LEAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION DID NOT INVOLVE A PATIENT. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9205651 ↗
• MalfunctionJan 31, 2019Break; Break

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST CENTRAL VENOUS CATHETER PLACEMENT, ALLEGEDLY A PUNCTURE WAS IDENTIFIED NEXT TO THE HUB AND THE LINE WAS REPAIRED. REPORTEDLY, THE PATIENT WAS HOSPITALIZED FOR SEPSIS AND PLACED ON PERIPHERAL INTRAVENOUS CANNULATION FOR FLUIDS AND ANTIBIOTICS. THE DEVICE WAS REMOVED AND REPLACED. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient; Sepsis

  MAUDE report 8294135 ↗