Deltec 21-2762-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10610586025556), received between Jun 12, 2017 and Sep 10, 2022 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K021999); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE NEEDLE WAS NOT CONTINUOUS AND COMPLETELY LOCKED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397567 ↗
• MalfunctionSep 9, 2022Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT WHEN THE USER INJECT THROUGH THE POWER PORT TUBING THE PRESSURE WILL RISE UP; BUT AT 300 PSI, IT WILL BE CONSIDERED PRESSURE LIMITING AND THE INJECTOR ITSELF WILL SUDDENLY DROP THE RATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397441 ↗
• MalfunctionSep 9, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE NEEDLE WAS SHOWING OBSTRUCTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397429 ↗
• MalfunctionSep 9, 2022Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT WHEN THE USER INJECT THROUGH THE POWER PORT TUBING THE PRESSURE WILL RISE UP; BUT AT 300 PSI, IT WILL BE CONSIDERED PRESSURE LIMITING AND THE INJECTOR ITSELF WILL SUDDENLY DROP THE RATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397413 ↗
• InjuryDec 27, 2017Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT DURING A BOLUS OF MEDICATION THROUGH A SMITHS MEDICAL DELTEC® GRIPPER PLUS® SAFETY NEEDLE THE PATIENT REPORTED TINGLING AND NOTED EDEMA TO THE SIDE OF THE PERFUSION. THE INFUSION WAS STOPPED, DOCTOR NOTIFIED AND EXTRAVASATION PROTOCOL INITIATED. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL OVERNIGHT FOR OBSERVATION AND DISCHARGED HOME THE FOLLOWING DAY WITH NO ADVERSE EFFECTS.

  Patient problems: Edema; Extravasation; Tingling

  MAUDE report 7149806 ↗
• InjuryOct 5, 2017Leak/Splash; Unstable; Leak/Splash; Unstable

  IT WAS ADDITIONALLY REPORTED THAT THE CURRENT STATE OF THE PATIENT WAS "WELL AND CONTROLLED". ANTIBIOTICS WERE ADMINISTERED.

  Patient problems: Sepsis

  MAUDE report 6918357 ↗
• InjuryJun 12, 2017Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A CHEMOTHERAPY TREATMENT, THE SAFETY DEVICE OF A DELTEC® GRIPPER PLUS® SAFETY NEEDLE DID NOT ENGAGE AND THE NEEDLE PRICKED THE NURSE. THE NURSE WENT TO THE EMERGENCY ROOM AND ACCIDENTAL BLOOD EXPOSURE PROTOCOL HAS BEEN FOLLOWED. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 6634846 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021999. One submission often covers many models, so check the product and lot details in each record.

• Z-0253-2020 · Jul 15, 2019 · Terminated
  Port full Access Tray Product Code: DT19330