Connecta, Luer-Lok 394910Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00382903949106), received between Mar 27, 2023 and Feb 12, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 reports).

3 FDA recall records name this device's identifier, 3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 21, 2026Class IIOpen, Classified

   Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.

   Z-2514-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Feb 20, 2025Class IIOpen, Classified

   Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)

   Z-1509-2025 · Root cause: Labeling Change Control · Recall details · FDA record ↗

3. May 9, 2022Class IIOpen, Classified

   May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.

   Z-1431-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Leak/Splash; Activation, Positioning or Separation Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327937 ↗
• MalfunctionJul 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD CONNECTA LEAKED THIS IS A COMPLAINT ABOUT DIPRIVAN LEAKAGE. THERE WAS A PROBLEM WITH THE CONNECTION TO THE FEMALE LUER AND THE DIPRIVAN LEAKED OUT. DETAILS ARE BEING CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22480314 ↗
• MalfunctionDec 8, 2023Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED THAT BD CONNECTA PLUS1 360 WHITE BLEND COMPONENT WAS DAMAGED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; IT WAS REPORTED BY CUSTOMER THAT CRACK IN THE STOPCOCK. VERBATIM: CRACK IN THE STOPCOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18294500 ↗
• MalfunctionNov 29, 2023Crack; Crack

  IT WAS REPORTED THAT BD CONNECTA PLUS1 360 WHITE BLEND HAD CRACKS THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; IT WAS REPORTED BY THE CUSTOMER THAT THERE WERE CRACKS IN THE STOPCOCKS. VERBATIM: WE HAVE RECEIVED PRODUCT WITH CRACKS IN THE STOPCOCKS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18229200 ↗
• MalfunctionNov 6, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT BD CONNECTA PLUS1 360 WHITE BLEND COMPONENT WAS DAMAGED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; VERBATIM: RCC RECEIVED COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. IT WAS REPORTED BY CUSTOMER THAT LEAKS AND CRACKS AFTER FEW MINUTES OF USING IT CAUSING LEAKS OF CHEMOTHERAPY DRUGS. I NEED TO KNOW WHAT MATERIAL THIS STOPCOCK IS MADE OUT OF? IT'S CALLED BD CONNECTS WITH REF #394910. WE ARE LOOKING FOR A 3-WAY-LUER-LOCK-STOPCOCK THAT IS RESISTANCE TO LIPIODOL. THIS ONE IS NOT AND LEAKS AND CRACKS AFTER FEW MINUTES OF USING IT CAUSING LEAKS OF CHEMOTHERAPY DRUGS.

  Patient problems: Insufficient Information

  MAUDE report 18080345 ↗
• MalfunctionJun 22, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT DURING USE WITH BD CONNECTA¿ STOPCOCK 3-WAY THE PRODUCT HAS A LOOSE COMPONENT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS REPORT ABOUT A LOOSE NEEDLE COVER. SINCE ABOUT A MONTH AGO, THE NEEDLE CAP OF THE SIDE INJECTION PART OF THE STOPCOCK HAS BEEN LOOSE AND ALMOST FALLING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17183111 ↗
• MalfunctionJun 5, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHILE USING BD CONNECTA PLUS STOPCOCK THE LABEL WAS MISSING INFORMATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED THAT THE PRINT ON THE PACKAGE WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17056668 ↗
• MalfunctionMar 27, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD CONNECTA¿ STOPCOCK 3-WAY EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT LEAKAGE WITH THE USE OF 385433-ZAT. ACCORDING TO THE CUSTOMER¿S REPORT, THE FLUID LEAKED FROM SOMEWHERE OF THE STOPCOCK ON 385433-ZAT.THE DRUG USED IS INOVAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16624559 ↗