Deltec 21-3367-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10610586033001), received between Mar 14, 2017 and Jul 3, 2026 — classified as 3 injuries, 18 malfunctions.

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

2 other recalls cover devices cleared under the same FDA submission (K072657); 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PORT NEEDLE COULDN'T BE INJECTED PROPERLY. DURING NEEDLE REMOVAL, IT WAS SUSPECTED THAT THE SAFETY DEVICE ACTIVATED DUE TO DAMAGE TO THE MAIN BODY. THE PATIENT WAS RECEIVING AN INFUSION THROUGH AN IMPLANTABLE INTRAVENOUS DRUG DELIVERY SYSTEM. AFTER 30 MINUTES OF INFUSION, THE NEEDLE REBOUNDED AND THE RIGHT-ANGLE NEEDLE BECAME DISLODGED, RESULTING IN PARTIAL EXTRAVASATION OF ONDANSETRON HYDROCHLORIDE INJECTION. A LOCAL SODIUM SULFATE COLD COMPRESS WAS APPLIED, AND A CHEST X-RAY WAS REPEATED TO CONFIRM THE PORT POSITION. THE EXTRAVASATION MAY REDUCE TREATMENT EFFECTIVENESS, INCREASE THE RISK OF INFECTION, CAUSE PATIENT ANXIETY, REQUIRE PORT CATHETER REMOVAL AND REIMPLANTATION, AND INCREASE PATIENT DISCOMFORT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25707460 ↗
• MalfunctionMar 10, 2026Retraction Problem

  IT WAS REPORTED THAT AFTER DE-ACCESSING THE PATIENT¿S PORT NEEDLE AND TAKING IT OUT OF THE PATIENT¿S BODY, GRIPPER PLUS POWER P.A.C NON-CORING SAFETY NEEDLE FOR POWER INJECTION DID NOT FULLY RETRACT INTO SAFETY MECHANISM. THIS LED TO NEEDLE STICK INJURY OCCURRING TO STAFF, NONE TO A PATIENT. THE EVENT OCCURRED AT THE HOSPITAL AT THE PATIENT¿S ROOM. THIS WAS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED AND REUSED ON A PATIENT. THIS WAS NOT EVER SERVICED BY A THIRD-PARTY SERVICER. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563353 ↗
• MalfunctionMar 2, 2026Retraction Problem

  IT WAS REPORTED THAT AFTER DE-ACCESSING THE PATIENT¿S PORT NEEDLE AND TAKING IT OUT OF THE PATIENT¿S BODY, GRIPPER PLUS POWER P.A.C NON-CORING SAFETY NEEDLE FOR POWER INJECTION DID NOT FULLY RETRACT INTO SAFETY MECHANISM. THIS LED TO NEEDLE STICK INJURY OCCURRING TO STAFF, NONE TO A PATIENT. THE EVENT OCCURRED AT THE HOSPITAL AT THE PATIENT¿S ROOM. THIS WAS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED AND REUSED ON A PATIENT. THIS WAS NOT EVER SERVICED BY A THIRD-PARTY SERVICER. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483953 ↗
• MalfunctionNov 12, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE DEVICE EXPERIENCED LAGS DURING INFUSION. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532338 ↗
• MalfunctionNov 11, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT BEFORE PUNCTURE, THE NURSE ROUTINELY CHECKED THE DRAINAGE FOR THE PATIENT AND FOUND DIFFICULTY IN DRAINAGE THROUGH THE NEEDLE AND IMMEDIATELY REPLACED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23522666 ↗
• MalfunctionSep 16, 2025Complete Blockage; Complete Blockage

  IT WAS STATED IN THE REPORT THAT IT WAS DIFFICULT TO DRAW BLOOD BACK AND PUSH FLUID AFTER THE PORT NEEDLE WAS INSERTED INTO THE INFUSION PORT. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063825 ↗
• MalfunctionAug 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ERYTHEMA AND TISSUE SWELLING AFTER THE DEVICE WAS IMPLANTED. THE REPORTER NOTED THAT THE PATIENT WAS FOUND WITH A SWOLLEN AREA OF ABOUT 20.0*18.0CM IN THE RIGHT LOWER ABDOMEN. AFTER REMOVING THE TRANSPARENT FILM, THE NURSE FOUND THAT HALF OF THE INDWELLING NEEDLE WAS EXPOSED. LIGHT BLOODY FLUID WAS SEEN IN THE WITHDRAWN FLUID, SO THE NURSE IMMEDIATELY REPORTED IT TO THE DOCTOR. THE DOCTOR REMOVED THE INDWELLING NEEDLE AND PERFORMED AN ULTRASOUND EXAMINATION ON THE PATIENT. THE RESPONSIBLE NURSE DISINFECTED IT AGAIN, REPLACED IT WITH AN IMPLANTABLE INTRAVENOUS DRUG DELIVERY SYSTEM OF ANOTHER SPECIFICATION, AND FLUSHED THE TUBE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: Erythema; Swelling/ Edema

  MAUDE report 22726201 ↗
• MalfunctionJul 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A POWER PORTABLE CATHETER (PAC) NEEDLE WAS BENT DURING A PROCEDURE. THE BENT NEEDLE WAS SAFELY REMOVED FROM THE PATIENT INTACT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22591330 ↗
• MalfunctionJun 26, 2025Complete Blockage; Difficult to Flush; Complete Blockage; Difficult to Flush

  THIS MDR IS BEING SENT TO COVER THE (B)(4) OTHER COMPLAINTS ON THE DEVICE THAT WERE MENTIONED IN MRN-3012307300-2025-07748. DUE TO THERE NOT BEING ENOUGH INFORMATION ABOUT THE OTHER 49 EVENTS, ALL THE 49 PRODUCTS WILL BE DOCUMENTED IN THIS MDR. IF MORE INFORMATION BECOMES AVAILABLE, INDIVIDUAL MDRS WILL BE SENT FOR THOSE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341241 ↗
• MalfunctionJun 26, 2025Complete Blockage; Difficult to Flush; Complete Blockage; Difficult to Flush

  IT WAS REPORTED THAT THE DEVICE COULD NOT BE FLUSHED. THE REPORTER NOTED THAT THE CLINICAL NURSE WAS FLUSHING AND SEALING THE TUBE BUT THE BLOOD AT THE HEAD OF THE PRODUCT COULD NOT BE FLUSHED REPEATEDLY. THE BLOOD GATHERED INSIDE THE CONNECTION BETWEEN THE NEEDLE TAIL AND THE CATHETER. THIS SITUATION OCCURRED AFTER USING MULTIPLE TUBES CONTINUOUSLY. THE PRODUCT WAS REPLACED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341111 ↗
• MalfunctionJun 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN FLUSHING THE PORT NEEDLE, FLUID LEAKED BETWEEN THE NEEDLE AND THE CONNECTING TUBE, AND THE NURSE IMMEDIATELY REPLACED THE PORT NEEDLE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319507 ↗
• MalfunctionJun 16, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE NDL, GRIPPER PLUS, PWR INJECTABLE, 20G X 0.75 SHOWED AN ISSUE DURING THE FLUSHING PROCEDURE. BLOOD AT THE HEAD END OF THE PRODUCT COULD NOT BE FLUSHED OUT DESPITE REPEATED ATTEMPTS. BLOOD ACCUMULATED AT THE CONNECTION BETWEEN THE NEEDLE TAIL AND THE CATHETER. THE PRODUCT HAD BEEN USED CONTINUOUSLY MULTIPLE TIMES. THERE WAS A PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214635 ↗
• MalfunctionMay 21, 2025Complete Blockage; Fluid/Blood Leak; Complete Blockage; Fluid/Blood Leak

  IT WAS REPORTED THAT, WHILE FLUSHING AND SEALING THE TUBES OF THE PRODUCT, THE BLOOD AT THE TIP OF THE PRODUCT COULD NOT BE FLUSHED OUT AND GATHERED AT THE CONNECTION BETWEEN THE NEEDLE TAIL AND THE CATHETER. THIS CONDITION OCCURRED AFTER FIVE CONSECUTIVE REPLACEMENTS. THE CUSTOMER REPORTED THAT IF BLOOD AGGREGATED AND ACCUMULATED TO FORM A THROMBUS THAT ENTERED THE VEINS, IT WOULD HAVE A SERIOUS IMPACT ON THE PATIENT. NO SPECIFIC PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061493 ↗
• MalfunctionApr 23, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO OBTAIN BLOOD RETURN, AND THE PLASTIC APPLICATOR REMAIN LODGED IN THE PORT. PATIENT INVOLVEMENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891519 ↗
• MalfunctionSep 3, 2024Contamination; Contamination

  IT WAS REPORTED THAT THERE WAS A DEAD SPACE FOUND AT THE CONNECTION BETWEEN THE TRANSPARENT EXTENSION TUBE AND THE METAL HANDLE DURING THE FLUSHING OF THE PORT NEEDLE, WHICH CAUSED BLOOD TO REMAIN AND COULD NOT BE RINSED CLEAN. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126005 ↗
• MalfunctionAug 22, 2024Backflow; Backflow

  IT WAS REPORTED THAT WHEN THE PATIENT USED IT, THE BLOOD BACKFLOW COULD NOT BE RECEDED AND THE AIR RECEDED. THERE WAS A PATIENT INVOLVEMENT, BUT NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032512 ↗
• MalfunctionMar 7, 2023Fluid/Blood Leak; Radiation Leak; Fluid/Blood Leak; Radiation Leak

  IT WAS REPORTED THAT THE PATIENT REPORTED AN APPROXIMATELY "3 INCH 5FU" (5-FLUOROURACIL) SPILL ON THEIR SHIRT DUE TO THE CONNECTOR AT THE TIP OF THE PORT COMING LOOSE. THEY STATED THE DEVICE WAS RECONNECTED BY THE PATIENT RIGHT AWAY AND NO BLOOD LEAKED FROM THE LINE. "ATC WAS NOT CALLED DURING THE SPILL BECAUSE IT WAS JUST A LITTLE PER THE PATIENT." THE DOCTOR WAS MADE AWARE OF THE EVENT. THE CONNECTOR CONNECTION WAS CHECKED, AND THE CONNECTOR DID EASILY DISCONNECT FROM TIP OF PORT-A-CATH CATHETER LINE. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16497489 ↗
• MalfunctionSep 5, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INFUSION NEEDLE WAS CROOKED WHEN INSERTED AND FELL OFF WHEN PULLED OUT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15354226 ↗
• InjuryOct 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DEVICE WAS PLACED IN USE WITH PATIENT IN HOME CARE FOR INFUSION OF FLUOROURACIL. THE REPORTER STATED THE PATIENT IDENTIFIED LEAKAGE WHERE THE NEEDLE MET THE PORTAL. THE PATIENT REPORTED TO EMERGENCY DEPARTMENT. NO FURTHER ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: Underdose

  MAUDE report 10624362 ↗
• InjuryMar 14, 2017Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT A DELTEC® GRIPPER PLUS® SAFETY NEEDLE DID NOT ENGAGE THE SAFETY STOP AND CAUSED A NURSE TO SUSTAIN A NEEDLESTICK. IT WAS NOTED THAT THE STICK DID NOT BREAK THE NURSE'S SKIN. NO PERMANENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00653.

  Patient problems: Needle Stick/Puncture

  MAUDE report 6403554 ↗
• InjuryMar 14, 2017Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT A DELTEC® GRIPPER PLUS® SAFETY NEEDLE DID NOT ENGAGE THE SAFETY STOP AND CAUSED A NURSE TO SUSTAIN A NEEDLESTICK. IT WAS NOTED THAT THE STICK DID NOT BREAK THE NURSE'S SKIN. NO PERMANENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00654.

  Patient problems: Needle Stick/Puncture

  MAUDE report 6403550 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072657. One submission often covers many models, so check the product and lot details in each record.

• Z-2499-2020 · Jun 11, 2020 · Terminated
  PORT-A-CATH II POWER P.A.C. Low Profile" system.
• Z-0190-2020 · Jul 8, 2019 · Terminated
  GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, TI, PU, 1.9MM, UL, 6FR/INTRO 1/EA; 2.