SOL-M™ Blunt Fill Needle with 5 Micron Filter 110022Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00818392015294), received between Mar 9, 2023 and Mar 18, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Defective Component” (11 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Defective Component

  CUSTOMER REPORTED DILUTED SOLU-CORTEF MEDICINE ON 22.1. NORMALLY BY PRESSING DOWN THE PLASTIC ACTIVATOR. REMOVED THE PROTECTIVE PLASTIC FROM THE STOPPER. PIERCED THE STOPPER WITH A BLUNT 18G 1 ½ SOL-M BLUNT FILL NEEDLE ATTACHED TO 2ML SYRINGE. WHEN DRAWING THE MEDICINE INTO THE SYRINGE, A PIECE OF THE STOPPER FLOATED IN THE MEDICINE. SO THE NEEDLE BIT OFF A PIECE OF THE STOPPER. UNFORTUNATELY THERE IS NO UNUSED SAMPLES FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634540 ↗
• MalfunctionJan 27, 2026Contamination

  CUSTOMER REPORTED THAT THEY USE SOL-M¿ BLUNT FILL NEEDLE 18G1½" REF: 110022 NEEDLES IN THE PREPARATION OF MEDICINES IN THE HOSPITAL PHARMACY. ON NOVEMBER 28, THE PHARMACIST IN THE PREPARATION WAS PREPARING MEDICINES WHEN HE NOTICED THAT THERE WAS A SMALL PIECE OF DEBRIS/HAIR AT THE TIP OF THE NEEDLE. HE DID NOT USE THE NEEDLE IN QUESTION, BUT PUT IT BACK IN THE SHEATH. THE NEEDLE IS AVAILABLE, WE HAVE NOT DISPOSED OF IT. THERE IS STILL A SMALL PIECE OF DEBRIS VISIBLE AT THE TIP. WE CANNOT GET A SUCCESSFUL PICTURE OF IT. ACCORDING TO THE PHARMACIST, THE DEBRIS WAS ACTUALLY LARGER, BUT SOME OF IT HAS DISAPPEARED AFTER THE NEEDLE HAS BEEN LOOKED AT AND PUT BACK IN THE SHEATH SEVERAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188167 ↗
• MalfunctionAug 1, 2025Defective Component; Defective Component

  CUSTOMER REPORTED THAT PARTICLES (CLEARLY VISIBLE) REMAIN IN THE BOTTLE AND IN THE SYRINGE FROM THE PUNCTURE CAP OF THE MEDICATION BOTTLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22683970 ↗
• MalfunctionAug 1, 2025Defective Component; Defective Component

  CUSTOMER REPORTED THAT A PIECE OF RUBBER GOT INTO THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22683969 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  CUSTOMER COMPLAINT NUMBER: (B)(4). CUSTOMER REPORTED THAT THE RUBBER PARTICLES INSIDE MEDICINE VIALS AND SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035693 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  CUSTOMER REPORTED: PRESENCE OF CORE RESIDUE IN A VIAL OF TAUROLOCK WITH AN INDIVIDUAL BLUNT SOL M NEEDLE. DEVICE/MEDICATION: TAUROLOCK U25000 + NEEDLE BLUNT SOL M 18G REF 110022 LOT NUMBER: LOT TAUROLOCK T2406 + LOT AIG 05304031.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035673 ↗
• MalfunctionMay 16, 2025Dull, Blunt; Dull, Blunt

  CUSTOMER REPORTED: THE CUSTOMER ADVISED THAT THEY HAVE HAD NUMEROUS ISSUES WITH THE BLUNT NEEDLES GETTING STUCK IN THE SEPTUM OF MEDICATION VIALS AND THEN SPRAYING STAFF WHEN THEY ARE FINALLY ABLE TO DISLODGE THE NEEDLE. THEY ARE RETURNING AS THEY FEEL THEY ARE HAZARDOUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035641 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  "DESCRIPTION OF THE INCIDENT: PHENOMENA OF "CORING" OF PIECES OF PLASTIC DURING THE PREPARATION OF VARIOUS INJECTABLE MOLECULES AT THE TIME OF SAMPLING THE PRODUCT FROM ITS CONTAINER. NEED FOR THOROUGH VISUAL INSPECTION TO DETECT THESE PLASTIC PARTICLES BEFORE STARTING THE INFUSIONS BY ELECTRIC SYRINGE. INCIDENTS MORE FREQUENT DURING THE PREPARATION OF PROPOFOL SYRINGES, BUT ALSO OBSERVED WITH OTHER MOLECULES. CURRENT CONDITION OF THE PATIENT: RISK OF INJECTION OF PLASTIC PARTICLES NEED FOR CAREFUL VISUAL INSPECTION BEFORE SETTING UP THE INFUSIONS LEADING TO AN INCREASE IN THE CARE LOAD WITH LOSS OF TIME AND NEED TO REMAKE A NEW SYRINGE IF PARTICLES ARE DISCOVERED AFTER PREPARATION. ACTIONS TAKEN IN THE CARE FACILITY FOR THE CARE OF THE PATIENT: REPEATED VISUAL INSPECTIONS BEFORE SETTING UP THE INFUSIONS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035635 ↗
• MalfunctionMay 16, 2025Dull, Blunt; Dull, Blunt

  CUSTOMER REPORTED: THE CUSTOMER ADVISED THAT THEY HAVE HAD NUMEROUS ISSUES WITH THE BLUNT NEEDLES GETTING STUCK IN THE SEPTUM OF MEDICATION VIALS, AND THEN SPRAYING STAFF WHEN THEY ARE FINALLY ABLE TO PULL THE NEEDLES OUT. THE CUSTOMER FEELS THAT THE NEEDLES ARE A HAZARD TO THEIR STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035628 ↗
• MalfunctionMay 16, 2025Dull, Blunt; Dull, Blunt

  CUSTOMER REPORTED: NEEDLE BENDING WHEN ADDING MEDICATION TO IV FLUID BAGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035622 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  CUSTOMER REPORTED THAT THEY SUFFERING A NEEDLE STICK INJURY.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22035604 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  "CUSTOMER REPORTED WE HAVE HAD 2 X INCIDENCES OF THE BLUNT NEEDLE CORING THE GREY VIAL RUBBER - THIS IS VERY UNUSUAL -DRAWN UP IN THE SYRINGE AND VIAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035582 ↗
• MalfunctionMay 16, 2025Dull, Blunt; Dull, Blunt

  CUSTOMER REPORTED: A CUSTOMER HAS REPORTED TO THAT THEY ARE EXPERIENCING TECHNICAL ISSUES WITH THE FOLLOWING PRODUCT/LOT. THE NEEDLE IS TOO BLUNT TO PUNCTURE THE INJECTION PORTS ON THEIR INTRAVENOUS FLUID BAGS. THE NEEDLE IS BENDING IN HALF WITHOUT PIERCING THE INTRAVENOUS FLUID INJECTION PORTS. IT SEEMS THE NEEDLE IS MUCH MORE BLUNT THAN USUAL. A NUMBER OF NURSES AND DOCTORS HAVE BROUGHT THIS ISSUE TO THEIR ATTENTION. THEY ARE VERY LARGE USERS OF THIS PRODUCT FOR MANY YEARS AND HAVE NEVER EXPERIENCED SIMILAR PROBLEMS BEFORE. IN CONSIDERATION OF 3 AND 4 IT WOULD SEEM TO ME THAT THIS LOT OF NEEDLE MUST BE TOO BLUNT - THEIR TECHNIQUE AND FEEL HAS NOT CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035572 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  CUSTOMER REPORTED THAT BLUNT NEEDLE LEADING TO CORING OF RUBBER TOP VIALS AS PICTURED IN THE ATTACHMENT. THE RUBBER DEBRIS AND COULD BE DRAWN UP INTO A SYRINGE AND ADMINISTERED TO A PATIENT. WE HAVE TESTED A NUMBER OF SOL-M NEEDLES ON DIFFERENT RUBBER TOP VIALS AND THEY HAVE CORE THE RUBBER EACH TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035487 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  "CUSTOMER REPORTED THAT THE RUBBER PARTICLES INSIDE MEDICINE VIALS AND SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035451 ↗
• MalfunctionMay 16, 2025Defective Component; Defective Component

  CUSTOMER REPORTED: NEW COMPLAINT REGARDING PINK NEEDLES THAT CAUSE RUBBER CORES WHEN USED TO PRICK MEDICINE BOTTLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22035423 ↗
• InjuryMar 9, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  I AM A PRACTICING ANESTHESIOLOGIST IN (B)(6). WHILE WORKING AT AN ENDOSCOPY CENTER, I RECENTLY OBSERVED A BIT OF DEBRIS FLOATING IN A SYRINGE OF PROPOFOL THAT I HAD DRAWN UP. I SET THE SYRINGE ASIDE; IT NEVER TOUCHED THE PATIENT. LATER INVESTIGATION REVEALS THAT THE 18 GAUGE BLUNT NEEDLE USED TO PIERCE THE POLYMER STOPPER ON THE VIAL HAD APPARENTLY CORED THE STOPPER AND THAT THE DEBRIS SEEN WAS THE POLYMER CORE. ONE CAN ONLY SPECULATE WHAT HARM MIGHT HAVE COME TO THE PATIENT IF THE DEBRIS HAD BEEN INJECTED INTO A VEIN. PERHAPS IT MAY HAVE BENIGNLY LODGED IN A CAPILLARY BED IN THE LUNG AND NEVER HAVE CAUSED A PROBLEM. PERHAPS IT MAY HAVE BECOME THE NIDUS OF AN INFECTION OR CLOT FORMATION, AND PERHAPS IT MAY HAVE SLIPPED THROUGH A PATENT FORAMEN OVALE AND BEEN SWEPT INTO THE CORONARY OR CEREBRAL CIRCULATION. IN ANY CASE, THIS WOULD SEEM TO BE A REPORTABLE EVENT. REGARDING TECHNIQUE, I AM HAPPY TO REPORT THAT I HAD DONE EVERYTHING BY THE BOOK AS I DO EVERY TIME. I USED A NEW SINGLE USE NEEDLE, A NEW UNACCESSED VIAL OF PROPOFOL, AND A NEW SINGLE USE SYRINGE. I SWABBED THE STOPPER ON THE VIAL WITH A 70% ISOPROPYL ALCOHOL PAD IMMEDIATELY PRIOR TO ACCESS. NOTE THAT PROPOFOL CANNOT BE DRAW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16512917 ↗