BD Q-Syte 385110Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 30382903851103), received between Aug 2, 2021 and Jun 30, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Leak/Splash

  ACCORDING TO THE CUSTOMER REPORT, THREE INSTANCES OF LIQUID LEAKAGE HAD OCCURRED DURING USE. THE AFFECTED PRODUCTS HAVE BEEN DISCARDED, BUT PLEASE CONFIRM WHETHER THE REMAINING PRODUCTS IN THE BOX ARE WITHIN OR OUTSIDE THE PRICE RANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25666732 ↗
• MalfunctionJun 11, 2026Leak/Splash

  THIS IS A REPORT ABOUT LIQUID LEAKAGE. ACCORDING TO THE CUSTOMER REPORT, LIQUID LEAKAGE OCCURRED WHEN A 21G WINGED NEEDLE WAS USED TO PUNCTURE THE RUBBER SEPTUM SECTION DURING USE. THE END USER IS (B)(6) ANIMAL HOSPITAL, LOCATED IN (B)(6). ADDITIONAL INFORMATION: WE RECEIVED A MESSAGE FROM A CUSTOMER SAYING THEY HAD ACCIDENTALLY DISCARDED THE DEFECTIVE ITEM. COULD YOU PROCEED WITHOUT THE ACTUAL PRODUCT?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25472388 ↗
• MalfunctionAug 20, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20002326 ↗
• MalfunctionAug 13, 2024Defective Component; Defective Component

  NO ADDITIONAL INFORMATION PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19976983 ↗
• MalfunctionSep 13, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE BD¿ PRN ADAPTER DISCONNECTED FROM THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS REPORT IS ABOUT DISCONNECTION OF THE PRODUCT FROM THE NEEDLE. THE CUSTOMER CLAIMS THAT DISCONNECTIONS OCCUR FREQUENTLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17740538 ↗
• MalfunctionFeb 14, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE PRN WAS FOUND SEPARATED FROM THE BD¿ PRN ADAPTER WHEN OPENING THE CARTON. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THIS IS A REPORT ABOUT SEPARATION OF THE RUBBER CAP OF PRN LUER SLIP ADAPTER. ACCORDING TO THE CUSTOMER'S VERBATIM REPORT, WHEN OPENING THE CARTON, THE RUBBER CAP WAS FOUND TO BE SEPARATED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16375222 ↗
• MalfunctionOct 11, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD¿ PRN ADAPTER LEAKED FROM THE LUER CONNECTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "ACCORDING TO THE CUSTOMER'S REPORT, LEAKAGE FROM THE RUBBER COMPONENT WAS OBSERVED. NO INFORMATION ON WHAT LEAKED WAS PROVIDED IN THE INITIAL REPORT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15575798 ↗
• MalfunctionApr 27, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A LUER-LOCK PRODUCT WAS MIXED INTO THE CARTON OF BD¿ PRN ADAPTERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THIS IS A REPORT ABOUT A MIXED PRODUCT. THE CUSTOMER REPORTED AS FOLLOWS: IN A CARTON OF PRN LUER SLIP ADAPTER (CAT#385110; LOT#0230628), ONE LUER LOCK PRODUCT WAS FOUND. THIS COMPLAINT PRODUCT WAS PLACED IN THE PACKAGE WITH THE PRODUCT INFORMATION OF CAT#385110 AND LOT#1194667."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14220133 ↗
• MalfunctionJan 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CAP SEPARATED FROM THE BD¿ PRN ADAPTER BEFORE UNPACKING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "ACCORDING TO THE VERBATIM REPORT OF THE CUSTOMER (ANIMAL CLINIC), PROTECTIVE CAP SEPARATION HAS BEEN FREQUENTLY OBSERVED BEFORE UNPACKING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13338038 ↗
• MalfunctionOct 7, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD¿ PRN ADAPTER LEAKED ANTICANCER MEDICATION ONTO THE ANIMAL'S SKIN DURING THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "DURING INFUSION OF AN ANTICANCER DRUG FOR A PET, THE LEAKAGE OCCURRED. AFTER I PLACED A NEEDLE/CATHETER AND CONNECTED IT TO PRN AND STARTED INFUSION AND THEN SAW THE FLUID LEAKING BETWEEN THE INTRAVENOUS CANNULA AND THE PRN ADAPTER, WHICH CAUSED A DAMAGE ON THE ANIMAL SKIN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12593864 ↗
• MalfunctionAug 2, 2021Material Discolored; Material Discolored

  IT WAS REPORTED THAT PRN LUER SLIP ADAPTER .75IN INJ SITE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT SUSPECTED PRODUCT DETERIORATION. THE RUBBER PART OF PRN ADAPTER WAS DISCOLORED AND HARD. THIS MIGHT BE DUE TO STORAGE CONDITIONS BUT WE DIDN'T USE THE COMPLAINT PRODUCT FROM A SAFETY STANDPOINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12264055 ↗