Deltec 21-3251-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10610586029745), received between Jul 6, 2020 and Sep 1, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fail-Safe Did Not Operate” (2 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 18, 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 1, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN ATTEMPTING TO ACCESS THE PATIENT'S PORT, IT WAS NOTED TO BE VERY MOBILE AND DIFFICULT TO ACCESS. IT WAS DIFFICULT TO REMOVE THE SAFETY NEEDLE AND UNABLE TO OBTAIN FLASHBACK OR FLUSH THE LINE. A SMALL ADJUSTMENT WAS MADE AND THEN THE LINE WAS ABLE TO BE FLUSHED WITH 1-2 MLS OF SALINE. THE PORT WAS REMOVED. A BLUNT CANNULA WAS NOTED TO BE BENT UPWARDS APPROXIMATELY 45 DEGREE FROM PERPENDICULAR FORM. THERE WAS A SMALL AMOUNT OF SWELLING AND BLEEDING AT THE PORT SITE. THE PATIENT WAS SENT TO THE HOSPITAL FOR FURTHER REVIEW AND ASSESSMENT. NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.

  Patient problems: Swelling/ Edema

  MAUDE report 15334517 ↗
• MalfunctionSep 23, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE NEEDLE WAS INSERTED INTO THE PORT LOCATED IN THE PATIENTS CHEST WALL. UPON REMOVAL, THE SHARP PORTION OF THE NEEDLE (HOUSED IN THE RETRACTABLE PORTION) WAS BENT. NO PATIENT INJURY BUT REQUIRED REPEAT ACCESS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12522849 ↗
• MalfunctionFeb 5, 2021Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THE DEVICE HAD BEEN IN USE WITH PATIENT AND USER HAD CAPTURED THE NEEDLE IN THE SAFETY MECHANISM. REPORTER STATED THE NEEDLE CAME OUT OF THE SAFETY MECHANISM AND USER SUSTAINED NEEDLE STICK. USER WAS GIVEN USER FACILITY'S NEEDLE STICK PROTOCOL. FURTHER INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED AT THIS TIME.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11287959 ↗
• MalfunctionFeb 5, 2021Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THE DEVICE HAD BEEN IN USE WITH PATIENT AND USER HAD CAPTURED THE NEEDLE IN THE SAFETY MECHANISM. REPORTER STATED THE NEEDLE CAME OUT OF THE SAFETY MECHANISM AND USER SUSTAINED NEEDLE STICK. USER WAS GIVEN USER FACILITY'S NEEDLE STICK PROTOCOL. FURTHER INFORMATION HAS BEEN REQUESTED AND NOT RECEIVED AT THIS TIME.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11287879 ↗
• MalfunctionNov 9, 2020Connection Problem; Fail-Safe Problem; Connection Problem; Fail-Safe Problem

  IT WAS REPORTED THAT THE DELTEC GRIPPER MICRO NEEDLES GRIPPER FAILED TO LATCH BACK INTO THE SAFETY LATCH. THE OPERATOR PULLED UP THE SAFETY ARM AND HEARD A CLICK SOUND. THE NEEDLE WAS LEFT EXPOSED. THIS PRODUCT PROBLEM WAS OBSERVED PRIOR TO PATIENT USE. THE PRODUCT WAS NOT USED ON THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10811622 ↗
• MalfunctionOct 28, 2020Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED THAT DUE TO A SMITHS MEDICAL GRIPPER MICRO NEEDLE NOT LOCKING INTO THE SAFETY, A NEEDLE STICK OCCURRED. NO PATIENT DEATH OR SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10745199 ↗
• MalfunctionJul 6, 2020Defective Component; Installation-Related Problem; Material Split, Cut or Torn; Defective Component; Installation-Related Problem; Material Split, Cut or Torn

  INFORMATION RECEIVED A SMITHS MEDICAL IMPLANTABLE PORTS/DELTEC GRIPPER MICRO NEEDLE CAUSED NEEDLE STICK TO NURSE. THIS EVENT WAS DESCRIBED WHEN REMOVING AND INTRODUCING NEEDLE, THE NURSE FELT A PRICK ON HAND AND NOTICED THE DEVICE HAD SPLIT INTO TWO PIECES; EXPOSING WITH SPLASH OF BLOOD. IT WAS REPORTED NURSE WAS INJURED BUT NO FURTHER DETAILED INFORMATION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 10235453 ↗