Deltec 21-2965-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10610586027734), received between May 27, 2016 and Sep 11, 2026 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  Patient problems: Extravasation; Pain; Swelling/ Edema

  MAUDE report 50741329 ↗
• MalfunctionJun 12, 2026Detachment of Device or Device Component

  AN EVENT INVOLVED A DELTEC GRIPPER PLUS NEEDLE WHERE IT WAS STATED THAT DURING THE REMOVAL OF THE DEVICE USED FOR ADMINISTERING ANTI-CANCER THERAPY, FROM THE PATIENT¿S PORT-A-CATH, A TAB FUNCTIONING AS THE PIVOT MECHANISM FOR NEEDLE ROTATION FAILED. THIS MALFUNCTION PREVENTED PROPER ENGAGEMENT WITH THE SAFETY SYSTEM AND RESULTED IN AN INJURY TO THE OPERATOR. THIS HAS THE POTENTIAL FOR EXPOSURE TO BLOODBORNE PATHOGENS. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN HARM REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 25484770 ↗
• MalfunctionJul 14, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT NOTIFIED DURING SHIFT HANDOVER THAT THEY HAD NUTRITION CONTENTS ON THEIR T-SHIRT. THE GRIPPER WAS OBSERVED TO BE IN PLACE, WITH NO SIGNS OF EXTRAVASATION. WHEN CHECKED, IT WAS ADMINISTERED SALINE SOLUTION AND LEAKAGE WAS NOTED AT THE PROXIMAL CONNECTION, WITH DROPS OF FLUID COMING FROM IT. THEREFORE, THE TOTAL PARENTERAL NUTRITION WAS SUSPENDED, THE GRIPPER WAS REMOVED USING THE PUSH-STOP TECHNIQUE. THE PRODUCT HAD BEEN USED FOR 4 DAYS. THERE WAS PATIENT INVOLVEMENT, AND THERE WAS NO PATIENT HARM, AND THE CONSEQUENCE OF THE EVENT WAS FILTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22494109 ↗
• MalfunctionJun 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN RINSING THE GRIPPER WITH A PRE-FILLED SYRINGE OF 0.9% NACL, IT LEAKED THROUGH THE TWO-WAY VALVE, EVEN THOUGH THE MAIN ACCESS WAS NOT SEALED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511987 ↗
• MalfunctionJun 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE GRIPPER LEAKS THROUGH THE UNUSED TWO-WAY VALVE WITHOUT OBSTRUCTING THE MAIN LINE. THE PATIENT RECEIVED SOME OF THE INJECTED MEDICATION ON HIS SHIRT DUE TO THE LEAKY VALVE, WITHOUT ANY FURTHER CONSEQUENCES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511531 ↗
• MalfunctionMay 13, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE HUBER NEEDLE WAS UNABLE TO BE PRIMED BY FLUSHING WITH SALINE BEFORE ACCESSING THE PATIENT. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19302327 ↗
• MalfunctionMar 4, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT FLUID LEAKED FROM THE BASE OF THE NEEDLELESS CONNECTOR SITE DURING USE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18832526 ↗
• MalfunctionJan 19, 2024Fluid/Blood Leak; Device Dislodged or Dislocated; Fluid/Blood Leak; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ¿A 48-HOUR DIFFUSER WAS FITTED TO THE PATIENT THE DAY BEFORE. TODAY, THE PATIENT RETURNED WITH THE NEEDLE SEEMINGLY AT AN ANGLE AND SLIGHTLY PROTRUDING FROM THE "PAC", AND WHITE MARKS ALL AROUND THE "PAC". IT WAS STATED THAT THE PATIENT'S PAJAMAS WERE SOAKED. THE NEEDLE WAS REMOVED, THE DIFFUSER (WITH 60 ML OF PRODUCT REMAINING) TAKEN BACK DOWN TO THE "UPC". A SIMILAR SITUATION (DOCUMENTED ON CN-254069) OCCURRED THE PREVIOUS DAY WITH ANOTHER PATIENT ON THE THIRD DAY OF HIM USING HIS DIFFUSER. HE CAME NORMALLY FOR HIS SESSION WITH TRACES OF SKIN DIFFUSION AROUND THE "PAC" AND THE NEEDLE VISIBLY OUT. HIS HOME NURSE HAD NOTICED A "LEAK" AROUND THE NEEDLE THE DAY BEFORE AND HAD TRIED TO REPLACE IT, WITHOUT BECOMING ALARMED OR CLAMPING THE PRODUCT.¿ THERE WERE NO CLINICAL CONSEQUENCES FOR THE PATIENTS. THE STATE OF THE EVENT IS RESOLVED. THE CUSTOMER CONFIRMED THAT THE DIFFUSER IS NOT AN ICU MEDICAL PRODUCT. THE SECOND EVENT STATED BY THE CUSTOMER INITIALLY (CN-254069) "DOES NOT CONCERN THEIR FACILITY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18547547 ↗
• MalfunctionApr 26, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE GRIPPER TUBING HAD LEAKAGE. NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 16817722 ↗
• MalfunctionOct 14, 2022Radiation Leak; Radiation Leak

  IT WAS REPORTED THAT THE SITE OF THE Y-CONNECTOR. IN ADDITION, A VENOUS RETURN AND BLOCKAGE OF THE IMPLANTABLE CHAMBER BY PROBABLE COAGULATION WERE REPORTED. THE SAME INCIDENT WAS NOTED BY A NURSE WHEN THE GRIPPER WAS REPLACED. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15610639 ↗
• MalfunctionOct 14, 2022Radiation Leak; Radiation Leak

  IT WAS REPORTED THAT THE PATIENT NOTICED A LEAKAGE OF CHEMOTHERAPY PRODUCT (5-FLUOROURACIL) WITH SKIN CONTAMINATION. IT WOULD BE A CRACK AT THE INJECTION SITE OF THE Y-CONNECTOR. IN ADDITION, A VENOUS RETURN AND BLOCKAGE OF THE IMPLANTABLE CHAMBER BY PROBABLE COAGULATION WERE REPORTED. THE SAME INCIDENT WAS NOTED BY A NURSE WHEN THE GRIPPER WAS REPLACED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 15607102 ↗
• MalfunctionOct 12, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE UNIT WAS DISCONNECTING DURING A CHEMOTHERAPY INFUSION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15586376 ↗
• MalfunctionSep 24, 2022Reflux within Device; Reflux within Device

  IT WAS REPORTED THAT THERE WAS NO BLOOD REFLUX DESPITE ATTEMPTS WITH THE SAME SAMPLE. THERE WERE NO ISSUES IDENTIFIED THE PREVIOUS TIMES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15476117 ↗
• MalfunctionSep 14, 2022Failure to Obtain Sample; Failure to Obtain Sample

  IT WAS REPORTED THAT THE DEVICE FAILED TO ASPIRATE DURING THE BLOOD COLLECTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422998 ↗
• MalfunctionSep 12, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT WITH THE SAME SAMPLE THERE WAS NO BLOOD REFLUX DESPITE ATTEMPTS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406807 ↗
• MalfunctionAug 31, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AIR WAS NOTICED WHEN PULLING BACK INTO THE SYRINGE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327348 ↗
• MalfunctionAug 31, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT AIR WAS NOTICED WHEN PULLING BACK INTO THE SYRINGE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327215 ↗
• MalfunctionMay 13, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE DEVICE WAS USED TO ACCESS PATIENT'S PORTAL AND THE USER COULD NOT ASPIRATE BLOOD BUT COULD NOT- AIR BUBBLES WERE SEEN. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11817340 ↗
• MalfunctionFeb 23, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT A NURSE NOTICED THE PRESENCE OF AIR IN A SMITHS MEDICAL SYRINGE ONCE THE NEEDLE WAS ALREADY INSTALLED. THE ISSUE OCCURRED TWICE. THEY USED ANOTHER NEEDLE FROM THE SAME LOT NUMBER AND THERE WERE NO ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11364528 ↗
• MalfunctionFeb 23, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT A NURSE NOTICED THE PRESENCE OF AIR IN A SMITHS MEDICAL SYRINGE ONCE THE NEEDLE WAS ALREADY INSTALLED. THE ISSUE OCCURRED TWICE. THEY USED ANOTHER NEEDLE FROM THE SAME LOT NUMBER AND THERE WERE NO ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11364397 ↗
• InjurySep 4, 2018Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT A PATIENT RECEIVING CHEMOTHERAPY VIA A SMITHS MEDICAL DELTEC® GRIPPER PLUS® SAFETY NEEDLE NOTICED LEAKING FROM THE ANTI-RETURN VALVE. THE PATIENT WENT TO THE EMERGENCY DEPARTMENT FOR EVALUATION. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7844186 ↗
• InjuryMay 17, 2017Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT A DELTEC® GRIPPER PLUS® SAFETY NEEDLE DID NOT ENGAGE INTO THE SAFETY DEVICE. THE NEEDLE HAD BEEN PUT ON THE CARE PLATE, AND WHILE THE NURSE TOOK THE COMPRESS, THE NEEDLE PRICKED THE NURSE. THE NURSE WENT THROUGH ACCIDENTAL BLOOD EXPOSURE PROTOCOL. NO PERMANENT INJURY TO PATIENT OR CLINICIAN WAS REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 6573157 ↗
• MalfunctionFeb 17, 2017Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING DEACCESS OF THE DELTEC® GRIPPER PLUS® SAFETY NEEDLE, THE NEEDLE WAS "PULLED UP THROUGH THE SAFETY OF THE DEVICE." ACCORDING TO THE REPORT, THE SAFETY OF THE DEVICE DID NOT LOCK AND NEEDLE WENT THROUGH THE BOTTOM OF THE PLASTIC BASE AND WAS FULLY EXPOSED. IT WAS REPORTED THAT NO MEDICAL INTERVENTION WAS REQUIRED AND THAT NO PATIENT OR CLINICIAN INJURY OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6341362 ↗
• MalfunctionMay 27, 2016Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING USE THE NEEDLE WOULD NOT ENGAGE INTO THE SAFETY MECHANISM. NO ADVERSE HEALTH OUTCOME RESULTED FROM THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5686691 ↗

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