Deltec 21-3271-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10610586029882), received between Jun 2, 2017 and Apr 21, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Leak/Splash

  IT WAS STATED A CHEMICAL LEAK HAS OCCURRED. THE OPERATOR IS REQUESTING TO INVESTIGATE WHERE AND HOW IT IS LEAKING. THE EVENT OCCURRED DURING USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24937908 ↗
• MalfunctionSep 4, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE NEEDLE IS HARD TO REMOVE WHEN THE SAFETY FUNCTION IS ACTIVATED, SO CUSTOMER USED OTHER PRODUCTS. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22962814 ↗
• MalfunctionJul 4, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE NEEDLE IS HARD TO REMOVE WHEN THE SAFETY FUNCTION IS ACTIVATED, SO CUSTOMER USED OTHER PRODUCTS. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22404180 ↗
• MalfunctionOct 17, 2024Complete Blockage; Fluid/Blood Leak; Complete Blockage; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A POSSIBILITY OF ROOT BLOCKAGE AS THE REMAINING AMOUNT OF CHEMICAL SOLUTION HAS NOT DECREASED. WHEN IT WAS DISCONNECTED FROM THE CONNECTED DISPOSABLE PCA PUMP, IT WAS CONFIRMED THAT CHEMICAL SOLUTION WAS LEAKING FROM THE PUMP ROUTE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471877 ↗
• MalfunctionOct 15, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS WITH THE DEVICE THERE WAS A SUSPECTED LEAKAGE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452724 ↗
• MalfunctionMay 30, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THERE WAS A TUBE OCCLUSION. WHEN TRYING TO PASS SALINE THROUGH THE TUBE BEFORE USE ON THE PATIENT, IT DID NOT PASS. THIS OCCURRED BEFORE PATIENT USE/DURING PRIMING AT FACILITY. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19425055 ↗
• MalfunctionJan 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT MEDICAL FLUID LEAKED "FROM NEAR THE INFUSION SITE". THE EVENT OCCURRED IN LATE NOV-2023. THIS OCCURRED DURING PATIENT USE. NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18446985 ↗
• InjuryApr 22, 2019Unintended Ejection; Material Fragmentation; Retraction Problem; Fail-Safe Did Not Operate; Unintended Ejection; Material Fragmentation; Retraction Problem; Fail-Safe Did Not Operate

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL GRIPPER MICRO NEEDLELESS Y-SITE LUER-ACTIVATED NEEDLELESS INJECTION SITE'S SAFETY ARM "SUDDENLY BROKE APART FROM THE INSERTER BASE" WHEN THE USER WAS READY TO DE-ACCESS THE CHEMO PORT AND THAT "THE SUDDEN DISLODGEMENT" OF THE SAFETY ARM CAUSED THE NEEDLE TO STICK THE USER'S RIGHT HAND ON THE WRIST. IMMEDIATELY FOLLOWING THE INCIDENT, THE USER REPORTED AN "INTENSE NUMBNESS" ON THEIR HAND AND CONTINUED TO CARRY OUT THEIR WORK WITH NO ACTIVE BLEEDING OR PAIN. THE NEXT MORNING, THE USER STATED THEY HAD A "SEVERE HEMATOMA" AND PAIN ON THEIR RIGHT HAND. GEL WAS THEN APPLIED TO REDUCE THE SWELLING. SUBSEQUENTLY, THE USER COMPLETED BLOOD TESTS, TOOK ANTI-INFLAMMATORY MEDICINE, AND WAS RECOMMENDED TO BE CLOSELY MONITORED FOR SIX MONTHS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hematoma; Needle Stick/Puncture; Numbness; Pain; Swelling

  MAUDE report 8537200 ↗
• InjuryJun 2, 2017Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT WHILE REMOVING A DELTEC® GRIPPER MICRO® BLUNT CANNULA, NON-CORING SAFETY NEEDLE, THE NEEDLE WAS EXPOSED AND STUCK THE CLINICIAN. IT WAS OBSERVED THAT THE BASE AND THE SAFETY ARM WERE SEPARATED. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 6609212 ↗