Deltec 21-3256-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10610586029790), received between Feb 9, 2017 and Feb 26, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (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 16, 2026.

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.

• MalfunctionFeb 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE ADMINISTERING AN INFUSION TO THE PATIENT, THE DOCTOR FOUND THAT THE DISPOSABLE IMPLANTABLE DRUG DELIVERY DEVICE'S INFUSION NEEDLE WAS DAMAGED, WITH BLOOD LEAKING, AND IT COULD NOT BE USED ON THE PATIENT, AND IT WAS PROMPTLY REPLACED WITH A NEW ONE. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455308 ↗
• MalfunctionJan 10, 2025Break; Break

  IT WAS REPORTED THAT THE NEEDLE SNAPPED DURING USE. THERE WAS PATIENT INVOLVEMENT. THE NEW PORT NEEDLE WAS USED TO ACCESS THE PATIENT'S IMPLANTED PORT. UPON DISPOSING OF THE INDUCER IN THE SHARPS BIN, THE SAFETY COVER, WHICH WAS SUPPOSED TO COVER THE GUIDE NEEDLE, POPPED BACK, EXPOSING THE NEEDLE AND RESULTING IN THE NEEDLE STABBING THE HEALTHCARE WORKER'S FINGER. THE DETAILS OF THE INJURY INDICATE A SHARPS INJURY SUSTAINED BY THE HEALTHCARE WORKER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21124083 ↗
• InjuryMay 4, 2023Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE NURSE WAS DE-ACCESSING A PORT AND THE SAFETY MECHANISM FAILED, RESULTING IN NEEDLESTICK AND BODILY FLUID EXPOSURE. THERE WAS A CLINICAL INJURY. PATIENT HAD BLOODBORNE DISEASE, RESULTING IN EXPOSURE OF THE HEALTHCARE TEAM MEMBER. TREATMENT INCLUDED MEDICAL PROPHYLAXIS FOR BLOODBORNE PATHOGEN. THE PATIENT DID NOT RECEIVE ANY MEDICAL TREATMENT. THE EVENT IS LISTED AS ONGOING DUE TO CONTINUED MEDICAL PROPHYLAXIS OF HEALTHCARE TEAM MEMBER. THE PATIENT INFORMATION WAS UNKNOWN.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 16869834 ↗
• InjuryMay 2, 2023Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE NURSE WAS DE-ACCESSING A PORT AND THE SAFETY MECHANISM FAILED, RESULTING IN NEEDLESTICK AND BODILY FLUID EXPOSURE. THERE WAS A CLINICAL INJURY. PATIENT HAD BLOODBORNE DISEASE, RESULTING IN EXPOSURE OF THE HEALTHCARE TEAM MEMBER. TREATMENT INCLUDED MEDICAL PROPHYLAXIS FOR BLOODBORNE PATHOGEN. THE PATIENT DID NOT RECEIVE ANY MEDICAL TREATMENT. THE EVENT IS LISTED AS ONGOING DUE TO CONTINUED MEDICAL PROPHYLAXIS OF HEALTHCARE TEAM MEMBER. THE PATIENT INFORMATION WAS UNKNOWN. TIME OF EVENT WAS 8:30.

  Patient problems: Exposure to Body Fluids; Needle Stick/Puncture

  MAUDE report 16856000 ↗
• MalfunctionJul 20, 2022Dull, Blunt; Difficult or Delayed Separation; Dull, Blunt; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE CANNULAS ARE PARTLY BLUNT, SO REPEATED PUNCTURING WAS NECESSARY AND THE SAFETY CLOSURE, WHICH MUST BE REMOVED AFTER PUNCTURE, WAS SO TIGHTLY ATTACHED THAT A STRONG PULL WAS NECESSARY. THERE WAS NO PERMANENT DAMAGE AND NO EXTRAVASATION, BUT THE REPEATED PUNCTURING OF THE CANNULA CAUSED PAIN FOR THE PATIENTS AND FEAR OF FURTHER PUNCTURING DUE TO THE TIGHT PULLING OF THE CLOSURE. NO INVASIVE INJURIES OCCURRED IN RELATION WITH PATIENTS.

  Patient problems: Anxiety; Pain

  MAUDE report 15066898 ↗
• MalfunctionJul 20, 2022Dull, Blunt; Difficult or Delayed Separation; Dull, Blunt; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE CANNULAS ARE PARTLY BLUNT, SO REPEATED PUNCTURING WAS NECESSARY AND THE SAFETY CLOSURE, WHICH MUST BE REMOVED AFTER PUNCTURE, WAS SO TIGHTLY ATTACHED THAT A STRONG PULL WAS NECESSARY. THERE WAS NO PERMANENT DAMAGE AND NO EXTRAVASATION, BUT THE REPEATED PUNCTURING OF THE CANNULA CAUSED PAIN FOR THE PATIENTS AND FEAR OF FURTHER PUNCTURING DUE TO THE TIGHT PULLING OF THE CLOSURE. NO INVASIVE INJURIES OCCURRED IN RELATION WITH PATIENTS.

  Patient problems: Anxiety; Pain

  MAUDE report 15066804 ↗
• MalfunctionJul 20, 2022Dull, Blunt; Difficult or Delayed Separation; Dull, Blunt; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE CANNULAS ARE PARTLY BLUNT, SO REPEATED PUNCTURING WAS NECESSARY AND THE SAFETY CLOSURE, WHICH MUST BE REMOVED AFTER PUNCTURE, WAS SO TIGHTLY ATTACHED THAT A STRONG PULL WAS NECESSARY. THERE WAS NO PERMANENT DAMAGE AND NO EXTRAVASATION, BUT THE REPEATED PUNCTURING OF THE CANNULA CAUSED PAIN FOR THE PATIENTS AND FEAR OF FURTHER PUNCTURING DUE TO THE TIGHT PULLING OF THE CLOSURE. NO INVASIVE INJURIES OCCURRED IN RELATION WITH PATIENTS.

  Patient problems: Anxiety; Pain

  MAUDE report 15066765 ↗
• MalfunctionFeb 9, 2017Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT A DELTEC® GRIPPER MICRO® BLUNT CANNULA SAFETY DEVICE FAILED WHILE A PATIENT PORT WAS BEING ACCESSED. THIS INCIDENT OCCURRED WITH A NURSE AND LEFT THE NEEDLE SLIGHTLY EXPOSED. NO PATIENT OR CLINICIAN INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6315686 ↗