Monoject 1188100777 (UDI 10192253034783)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10192253034783), received between Apr 14, 2024 and Sep 5, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 25, 2024Open, Classified

   Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.

   Z-0310-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  CUSTOMER FEEDBACK: AFTER INSULIN IS DRAWN UP IN THIS SYRINGE, RECAPPING THE SYRINGE PUSHES 1-2 UNITS OF AIR INTO THE SYRINGE CAUSING IT TO APPEAR AS THOUGH THE DOSE IS LARGER THAN IT ACTUALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20142292 ↗
• MalfunctionJul 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19786274 ↗
• MalfunctionJul 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THIS ITEM HAS CAUSED TWO NEAR MISSES BECAUSE OF THE ELONGATED PLUNGER ON THE SYRINGE AND HAS BECOME A SAFETY ISSUE FOR CLINICIANS ADMINISTERING THE DOSAGE, DUE THE CHANGE MADE ON THE CONICAL PLUNGER IN NOVEMBER.THE CUSTOMER REPORTED THAT THE ITEM HAS CAUSED A NEAR MISS BECAUSE OF THE ELONGATED PLUNGER ON THE SYRINGE AND STATED IT HAS BECOME A SAFETY ISSUE FOR CLINICIANS ADMINISTERING THE DOSAGE, DUE THE CHANGE MADE ON THE CONICAL PLUNGER IN NOVEMBER. ADDITIONAL INFORMATION RECEIVED ON 27MAR2024 STATED THAT IN THE ACUTE CARE UNIT A NURSE DREW UP ORDERED 10 UNITS INSULIN IN THE MONOJECT 1 ML INSULIN SYRINGE WITH LUER-LOCK WITH TIP CAP (U-100). LOT #221201. PER THEIR SAFETY PRACTICE, SHE WENT TO OBTAIN DUAL VERIFICATION OF THE DOSE DRAWN UP FROM A SECOND NURSE. THE SECOND NURSE WAS CONFUSED BY THE NEW DESIGN AND WAS NOT CERTAIN WHERE TO MEASURE THE DOSE (BASE OF PLUNGER OR CONICAL TIP OF PLUNGER). THE SECOND NURSE ADVISED DISCARDING AND DRAWING UP DOSE IN A SQ SYRINGE WHERE IT WAS CLEAR TO USE THE BASE OF PLUNGER AS DOSE MARKER. THE DOSE WAS DRAWN UP USING CONICAL TIP OF PLUNGER -IF GIVEN, THAT WOULD HAVE BEEN 27 UNITS OF INSULIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19786273 ↗
• MalfunctionJul 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE NEW MONOJECT CARDINAL BRANDED 1ML INSULIN SYRINGE 1188100777 ARE NOT PERFORMING THE SAME AS THE PREVIOUS BRANDED COVIDIEN PRODUCT. THE PLUNGER HAS LITTLE RESISTANCE IN DELIVERING MEDICATION AND LEAKAGE IS OCCURRING. PATIENT SAFETY ISSUE DUE TO DRIP OF MEDICATION FROM TIP. RESISTANCE DIFFERENCE BETWEEN COVIDIEN PRODUCT AND CARDINAL BRAND CONICAL TIP AND VISIBILITY OF GRADUATION MARKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19786270 ↗
• MalfunctionJul 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  RECENT CHANGES TO SYRINGES WILL AFFECT DOSAGE. SPECIFICALLY THE CONICAL PLUNGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19786269 ↗
• MalfunctionJun 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED ANONYMOUSLY VIA MEDWATCH THAT A NURSE REPORTED AN ISSUE WITH AN IV INSULIN SYRINGE. THE NURSE REPORTED DIFFICULTY ADMINISTERING THE FULL INSULIN DOSE INTO THE IV LINE AS SOME OF THE MEDICATION WAS STUCK IN THE SYRINGE AND UNABLE TO BE EXPELLED INTO THE IV LINE. AFTER INVESTIGATION, IT WAS DISCOVERED THAT THE MANUFACTURER OF THE IV INSULIN SYRINGE HAS RECENTLY CHANGED DESIGN WITH THE SAME REF NUMBER ((B)(4)) USED. WHEN USED WITH A MICROCLAVE CLEAR NEUTRAL CONNECTOR, THE PREVIOUS DESIGN BY COVIDIEN ALLOWED THE ENTIRE CONTENTS OF THE SYRINGE TO BE ADMINISTERED INTO THE PATIENT IV LINE. THE NEW DESIGN BY CARDINAL HEALTH DOES NOT ALLOW FOR ALL OF THE CONTENTS OF THE SYRINGE TO BE ADMINISTERED INTO THE PATIENT IV LINE. THE DEMONSTRATION SHOWS THAT APPROXIMATELY 2-3 UNITS ARE LEFT IN THE SYRINGE. THIS POSES A SAFETY RISK AS A PATIENT WITH HYPERKALEMIA MAY NOT BE RECEIVING THE FULL ORDERED DOSE USING THE NEW SYRINGE DESIGN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19592079 ↗
• MalfunctionJun 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE 1 ML INSULIN SYRINGE WERE CHANGED FROM THE COVIDIEN BRAND TO THE CARDINAL HEALTH BRAND. THE DIFFERENCE BETWEEN THE 2 IS THE PLUNGER ASPECT OF THE SYRINGE. WHEN THEY HAVE OR PATIENTS, THEY ARE HOOKED UP TO A LARGER BORE, SINGLE LUMEN TUBING. THE NEW SYRINGES WILL NOT ALLOW THEM TO PUSH THE SMALL AMOUNT OF INSULIN DUE TO THE PRESSURE THAT THE LONGER PLUNGER CAUSES IN THIS TUBING. THE REFERENCE NUMBER IS THE EXACT SAME, HOWEVER THE SYRINGE IS DIFFERENT AND IS AFFECTING THEM BEING ABLE TO PROPERLY GIVE PATIENTS THEIR IV INSULIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19592075 ↗
• MalfunctionJun 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THE INSULIN SYRINGES STATING THAT THE CONCERN IS A MEDICATION ERROR. THEY STATED THAT THE LONG BLACK PIECE (THE PLUNGER) IN THE MIDDLE OF THE SYRINGE IS MAKING IT DIFFICULT TO SEE HOW MUCH MED IS BEING DRAWN. THEY WOULD LIKE TO GO BACK TO THE PREVIOUS SYRINGE (THE ONES WITHOUT THE CONICAL PLUNGER). ON (B)(6) 2024 THE INITIAL REPORTER CONFIRMED THERE WAS NO ACTUAL MEDICATION ERROR, IT IS ONLY A CONCERN/RISK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19591780 ↗
• MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THEY SUSPECT THE SYRINGE INACCURATE INCORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102865 ↗