NA 2C6250Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00085412036311), received between Jan 15, 2025 and Nov 17, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionNov 17, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE PACKAGING OF A DUAL LUER LOCK CAP WAS MISSING THE USUAL PULL-OPEN TAB, WHICH MADE IT DIFFICULT TO MAINTAIN THE STERILITY OF THE CAP. ADDITIONALLY, THE "OPEN HERE" END OF THE PACKAGING WAS SEALED SHUT, NURSES NEEDED TO USE SCISSORS TO OPEN THE PACKAGE. THIS OCCURRED DURING UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23570710 ↗
• MalfunctionOct 31, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT A DUAL LUER LOCK CAP - KIPPMED WAS VERY CHALLENGING TO OPEN THE PACKAGE. THE ISSUE OCCURRED DURING USE WHILE TRYING TO PUT ON A SYRINGE WITH DILUTED MEDICATION. SCISSOR WAS USED TO OPEN THE PACKAGING, RESULTING IN CAPS LANDING ON THE FLOOR OR BEING CONTAMINATED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437405 ↗
• MalfunctionOct 28, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE PACKAGING OF AN UNSPECIFIED QUANTITY OF DUAL LUER LOCK CAPS WERE CHALLENGING TO OPEN. SCISSORS WERE USED TO TRY TO RIP THE PACKAGING RESULTING IN MANY CAPS LANDING ON THE FLOOR OR BEING CONTAMINATED. THE ISSUE WAS FURTHER DESCRIBED AS "THE EDGES PROVIDE NO LOSE EDGE FOR STAFF TO BE ABLE TO TEAR AWAY THE CLEAR PACKAGING FROM THE WHITE BACKING". THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404766 ↗
• MalfunctionJul 31, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE PACKAGING OF AN UNSPECIFIED AMOUNT OF DUAL LUER LOCK CAPS WAS DIFFICULT TO OPEN. THE PACKAGING REQUIRED USING SCISSORS WHICH COMPROMISED THE STERILITY. THIS OCCURRED DURING SETUP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680087 ↗
• MalfunctionJul 21, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE STERILE PACKAGING OF AN UNSPECIFIED QUANTITY OF DUAL LUER LOCK CAP, MALE/FEMALE PORT PROTECTORS WERE DIFFICULT TO OPEN. THESE PACKAGES WERE OFTEN CHALLENGING TO OPEN, SOMETIMES REQUIRING SCISSORS WHICH MAY COMPROMISE STERILITY. ADDITIONALLY, THE PACKAGING LACKS A CLEAR PEEL POINT, MAKING IT DIFFICULT TO OPEN. THESE ISSUES WERE OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555825 ↗
• MalfunctionJan 16, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT UNSPECIFIED QUANTITY OF DUAL LUER LOCK CAPS WERE LOOSE ON NON-BAXTER SYRINGES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172812 ↗
• MalfunctionJan 15, 2025Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT A DUAL LUER LOCK CAP WAS LOOSE ON A NON-BAXTER SYRINGE RESULTING IN A LEAK OF SOLUTION ON THE PATIENT'S HAND. THIS WAS NOTICED WHILE OPENING THE PACKAGING OF A CYTARABINE INJECTION FOR ADMINISTRATION. THE EVENT WAS FURTHER DESCRIBED AS "THE SYRINGE WAS WET AND BLUE CAP AT THE SYRINGE HUB/TIP WAS LOOSE." THE PATIENT PROCEEDED WITH THE DRUG ADMINISTRATION. THE PATIENT WAS INSTRUCTED TO WASH THEIR HANDS AND CLEAN THE AREA WHERE THE MEDICATION WAS PREPARED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162038 ↗