SOL-CARE™ Safety Blood Collection Needle w/Pre-attached Holder 110201030004Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00818392015591), received between May 15, 2025 and May 16, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Dull, Blunt; Dull, Blunt

  CUSTOMER REPORTED: INCIDENT DESCRIPTION: PAIN WHEN TRYING TO EXTRACT BLOOD FROM A PATIENT IMMOBILIZED AT HOME. THE EXTRACTION COULD NOT BE PERFORMED WITH THIS MATERIAL. CONSEQUENCES FOR THE PATIENT: PAIN DURING PUNCTURE AND POSSIBLE HEMATOMA AFTER UNSUCCESSFUL SEARCH MANEUVER TO CANALIZE THE VEIN. COMMENTS: SINCE WE HAVE BEEN USING THIS TYPE OF MATERIAL, COMPLAINTS FROM PROFESSIONALS AND PATIENTS ARE DAILY IN THE LABORATORY OF THIS HEALTH CENTER, PROBLEMS WITH CANALIZING VEINS, PAIN FOR PATIENTS DURING PUNCTURE. PREVIOUSLY, WITH ANOTHER MANUFACTURER OF WING NUTS, THIS WAS OCCASIONAL.

  Patient problems: Pain

  MAUDE report 22035625 ↗
• MalfunctionMay 16, 2025Complete Blockage; Complete Blockage

  "INCIDENTS DESCRIPTIONS: THE HEALTH CARE PROFESSIONAL IS DESCRIBING 3 DIFFERENT ISSUES OCCURRED WITH THE NEEDLES, PLEASE EVALUATE EACH OF THEM INDIVIDUALLY. - ON MANY OCCASIONS THE BLOOD DOES NOT REFLUX DESPITE THE FACT THAT WE LATER VERIFY THAT WE ARE IN A VEIN. - ALTHOUGH THE MEASUREMENTS ARE THE SAME, WE HAVE VERIFIED THAT THE NEEDLES ARE SHORTER. - PRE-ASSEMBLED PIPE HOLDER IS EASILY DISCONNECTED DURING TUBE CHANGES. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035573 ↗
• MalfunctionMay 16, 2025Decoupling; Decoupling

  "IT WAS REPORTED: ACCORDING TO THE HOSPITAL, THE NURSES AT THE BLOOD COLLECTION UNIT, WHILE PERFORMING THE BLOOD COLLECTION PROCEDURE, ONCE THEY ARE DRAWING UP BLOOD SOME OF THE TUBES GET EXPELLED. AT THE SAME TIME, THE TUBE HOLDER WAS COVERED BY BLOOD FROM THE BLOOD COLLECTION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035567 ↗
• MalfunctionMay 15, 2025Complete Blockage; Complete Blockage

  INCIDENTS DESCRIPTIONS: THE HEALTH CARE PROFESIONAL IS DESCRIBING 3 DIFFERENT ISSUES OCURRED WITH THE NEEDLES, PLEASE EVALUATE EACH OF THEM INDIVIDUALLY. ON MANY OCCASIONS THE BLOOD DOES NOT REFLUX DESPITE THE FACT THAT WE LATER VERIFY THAT WE ARE IN A VEIN. THE NEEDLES ARE SHORTER THAN OTHER SIMILAR PRODUCTS. THE HOODS ARE EASILY DISASSEMBLED, INCREASING THE RISK OF THE HEALTH PROFESSIONAL BEING PUNCTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031354 ↗
• MalfunctionMay 15, 2025Complete Blockage; Complete Blockage

  "INCIDENTS DESCRIPTIONS: (THE HEALTH CARE PROFESSIONAL IS DESCRIBING 3 DIFFERENT ISSUES OCCURRED WITH THE NEEDLES, PLEASE EVALUATE EACH OF THEM INDIVIDUALLY). ON MANY OCCASIONS THE BLOOD DOES NOT FLOW DESPITE BEING IN A VEIN, THE NEEDLES ARE SHORTER THAN OTHER SIMILAR PRODUCTS. THE HOODS ARE EASILY DISASSEMBLED, INCREASING THE RISK OF THE HEALTH PROFESSIONAL BEING PUNCTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031352 ↗
• MalfunctionMay 15, 2025Complete Blockage; Complete Blockage

  CUSTOMER REPORTED: INCIDENTS DESCRIPTIONS: (THE HEALTH CARE PROFESIONAL IS DESCRIBING 3 DIFFERENT ISSUES OCURRED WITH THE NEEDLES, PLEASE EVALUATE EACH OF THEM INDIVIDUALLY)THESE BLOOD COLLECTION SYSTEMS ARE GIVING US A LOT OF PROBLEMS. LIST:- ON MANY OCCASIONS THE BLOOD DOES NOT FLOW EVEN THOUGH WE LATER VERIFY THAT THEY ARE IN A VEIN- ALTHOUGH THE MEASUREMENTS ARE THE SAME AS THE REST OF THE SYSTEMS, WE HAVE VERIFIED THAT THE NEEDLES ARE SHORTER. PHOTOS ARE ATTACHED- PRE-ASSEMBLED PIPE HOLDER IS EASILY DISCONNECTED DURING TUBE CHANGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031349 ↗