Q-Syte 385158Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00382903851584), received between Nov 22, 2022 and Jul 7, 2025 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414268 ↗
• MalfunctionAug 28, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE IV SET SEPARATED FROM THE BD Q-SYTE¿ TRI-EXTENSION SET'S SPLIT-SEPTUM DURING THE INFUSION. THIS OCCURRED WITH 3 EXTENSION SETS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IV SET GETTING SLIPPED FROM SPLIT SEPTUM OF QSYTE TRI EXTENSION SET, INABILITY TO CONTINUE INFUSION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638394 ↗
• MalfunctionAug 10, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE PM LINE DISCONNECTED FROM THE BD Q-SYTE¿ TRI-EXTENSION SET WHILE TRYING TO INSERT IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN ICCU, WHEN THE PM LINE WAS TRIED TO BE INSERTED WITH ONE OF THE EXTENSION OF THE Q-SYTE TRI-EXT, THE PM LINE WAS GETTING POP-OUT AND NOT FIXING WHEN ROTATING"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17503248 ↗
• MalfunctionAug 6, 2023Leak/Splash; Defective Component; Leak/Splash; Defective Component

  IT WAS REPORTED THAT THE SYRINGES COULD NOT BE INSERTED INTO THE 2 DAMAGED BD Q-SYTE¿ TRI-EXTENSION SETS AND MEDICATION LEAKED AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOT ABLE TO INSERT THE SYRINGES IN THE SPLIT SEPTUM. UNABLE TO GIVE MEDICATION AND DRUG SPILL IS HAPPENING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17467414 ↗
• MalfunctionJun 6, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD Q-SYTE¿ TRI-EXTENSION SET WAS BLOCKED WHILE ATTEMPTING TO DELIVER MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNABLE TO GIVE MEDICATION THROUGH LUMENS OF Q-SYTE TRI EXTENSION. ISSUE SEEN WHILE GIVING MEDICATIONS IN OT AREA TO PEDIATRIC PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070905 ↗
• MalfunctionMay 30, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD Q-SYTE¿ TRI-EXTENSION SET SEPTUM WAS BLOCKED. THIS OCCURRED 20 TIMES EACH IN LOTS 2033442, 2060348, AND 2122453. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING A DISCUSSION WITH THE CUSTOMER, THE HEALTHCARE WORKER FOUND THAT THE SILICON SEPTUM ENTRANCE (HUB) OF Q-SYTE TRI EXTENSION SMALL BORE WAS BLOCKED. HAVE TO CREATE ANOTHER INDENT BY HEALTHCARE WORKER DUE TO THIS BLOCKED SEPTUM"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17024579 ↗
• MalfunctionApr 13, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT MEDICATION LEAKED FROM THE TOP OF THE BD Q-SYTE¿ TRI-EXTENSION SET SEPTUM. THIS OCCURRED WITH 5 SETS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NOT ABLE TO INSERT THE SYRINGES IN THE SPLIT SEPTUM. SO THAT UNABLE TO GIVE MEDICATION AND ALSO DRUG SPILL IS HAPPENING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740494 ↗
• MalfunctionMar 29, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD Q-SYTE¿ MICROBORE TRI-EXTENSION THE CONNECTION WAS DIFFICULT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE USER IS TRYING TO PRIME THE Q SYTE TRI EXTENSION 385158, NOT ABLE TO PRIME TWO LUMENS DUE TO RESISTANCE IN SEPTUM AND NOT ABLE TO CONNECT POSIFLUSH LUE LOK TO Q SYTE. ALREADY RAISED THE SAME COMPLAINT WITH RESPECT TO OTHER BATCH FEW MONTHS BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16638980 ↗
• MalfunctionFeb 11, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED WHILE USING BD Q-SYTE¿ MICROBORE TRI-EXTENSION THERE WERE FLOW ISSUES AND BLOCKAGES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD Q-SYTE SMALL BORE TRI EXT. 2 LUMEN BLOCKED. IN ICU BD Q-SYTE TRI EXT. IS GETTING USED, AND SEPTUM IS CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16359736 ↗
• MalfunctionJan 20, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED WHILE USING BD Q-SYTE¿ MICROBORE TRI-EXTENSION THERE WAS A CLOG. THIS OCCURRED 30 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2.THERE ALL 3 ACCESS POINT OF QSYTE TRI EXTN IS BLOCK AND UNABLE TO INSERT IV SET / SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16219085 ↗
• MalfunctionJan 20, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED WHILE USING BD Q-SYTE¿ MICROBORE TRI-EXTENSION THERE WAS A CLOG. THIS OCCURRED 30 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. THERE IS 2 ACCESS POINT OF QSYTE TRI EXTN IS BLOCK AND UNABLE TO INSERT IV SET / SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16219072 ↗
• MalfunctionJan 19, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE ONE OF THE EXTENSIONS ON THE BD Q-SYTE¿ TRI-EXTENSION SET WAS BLOCKED DURING THE FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS COMPLAINING OF THE DEFECT IN ONE OF THE EXTENSIONS IN THE BD Q-SYTE TRI-EXTENSION SET.WHILE CUSTOMER PERFORMING FLUSHING OF ALL THREE EXTENSIONS ONE OF THE EXTENSION IS NOT WORKING AND FLUSH IS NOT GETTING FIXED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16210362 ↗
• MalfunctionJan 6, 2023Complete Blockage; Fitting Problem; Complete Blockage; Fitting Problem

  IT WAS REPORTED THAT THE BD Q-SYTE¿ TRI-EXTENSION SET LUER CONNECTION WAS UNABLE TO CONNECT TO THE POSIFLUSH SYRINGE, RESULTING IN THE INABILITY TO PRIME ALONG WITH HAVING RESISTANCE IN THE SEPTUM. THESE EVENTS OCCURRED 4 TIMES EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE USER IS TRYING TO PRIME THE Q SYTE TRI EXTENSION 385158, NOT ABLE TO PRIME TWO LUMENS DUE TO RESISTANCE IN SEPTUM AND NOT ABLE TO CONNECT POSIFLUSH LUE LOK TO Q SYTE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118072 ↗
• MalfunctionDec 22, 2022Break; Break

  IT WAS REPORTED THAT THE BD Q-SYTE¿ MICROBORE TRI-EXTENSION EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1 OUT OF 3 CLOSE SEPTUMS IS LOCKED; UNABLE TO OPEN WITH NORMAL SYRINGE PUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16039667 ↗
• MalfunctionDec 22, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 5 BD Q-SYTE EXTENSION SETS WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAIN RAISED FOR Q SYTE TRI EXTENSION FROM BMT DEPT. OF HCG HOSPITAL. OUT OF 3 PORTS,2 PORTS ARE BLOCKED AND CUSTOMER NOT BEEN ABLE TO PRIME. THE INCIDENT REPORTED WITH 3 UNITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16032182 ↗
• MalfunctionDec 20, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT 3 BD Q-SYTE EXTENSION SETS WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: QSYTE TRI EXTENSION SMALL BORE : HAVE ALL 3 SEPTUMS WITH UNABLE TO OPEN WITH NORMAL NEEDLE PUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018975 ↗
• MalfunctionDec 16, 2022No Flow; No Flow

  IT WAS REPORTED WHILE USING BD Q-SYTE¿ MICROBORE TRI-EXTENSION THERE WERE FLOW ISSUES AND A BLOCKAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN DELUXE WARD DURING PRIMING OF Q SYTE TRI EXTENSION LUMENS, USER CAN PRIME ONLY ONE LUMEN AND REST TWO LUMENS ARE NOT ABLE TO PRIME WITH BD POSIFLUSH, NOT ABLE TO PUSH THE PLUNGER AS THERE IS A RESISTANCE. WHEN USER SECURE BD POSIFLUSH AND TRYING TO PRIME THEY ARE NOT ABLE TO PUSH THE PLUNGER AS THERE IS A RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000528 ↗
• MalfunctionDec 16, 2022No Flow; No Flow

  IT WAS REPORTED WHILE USING BD Q-SYTE¿ MICROBORE TRI-EXTENSION THERE WAS A BLOCKAGE. THIS OCCURRED 150 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING PRIMING OF Q SYTE TRI EXTENSION LUMENS, USER CAN PRIME ONLY ONE LUMEN AND REST TWO LUMENS ARE NOT ABLE TO PRIME. WHEN USER SECURE BD POSIFLUSH AND TRYING TO PRIME THEY ARE NOT ABLE TO PUSH THE PLUNGER AS THERE IS A RESISTANCE. AGAIN IF THEY TRY TO CONNECT POSIFLUSH WE CAN SEE REBOUND OF POSIFLUSH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15998733 ↗
• MalfunctionDec 15, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD Q-SYTE¿ TRI-EXTENSION SET WAS BLOCKED AND MEDICATION COULDN'T BE INFUSED DURING USE. THIS OCCURRED WITH 10 SETS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HEALTHCARE WORKER IS UNABLE TO INFUSE THE MEDICATION FROM THE LUMENS OF QSYTE TRI EXTENSION"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15991277 ↗
• MalfunctionDec 6, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED WHILE USING BD Q-SYTE¿ MICROBORE TRI-EXTENSION THERE WERE FLOW ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: QSYTE TRI EXTENSION LUMENS UNABLE TO INFUSE MEDICATIONS , ITS FOUND THAT OUT OF THREE LUMENS HEALTHCARE WORKER IS UNABLE TO INFUSE MEDICATIONS IN TWO LUMENS , I AM SENDING THE AFFECTED SAMPLE FOR THE INVESTIGATION AND AN UNOPENED SAMPLE ALSO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15929337 ↗
• MalfunctionDec 2, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 BD Q-SYTE 15CM SMALL BORE TRI-EXT SET EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD Q SYTE TRI EXTENSION PORT WAS BLOCKED DUE TO WHICH THEY ARE NOT ABLE TO USE AND THEIR WAS LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15901424 ↗
• MalfunctionDec 1, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT 2 BD Q-SYTE 15CM SMALL BORE TRI-EXT SET EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD Q SYTE TRI EXTENSION PORT WAS BLOCKED DUE TO WHICH THEY ARE NOT ABLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15900189 ↗
• MalfunctionNov 30, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 3 BD Q-SYTE 15CM SMALL BORE TRI-EXT SETS WERE NOT ABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE USER IS TRYING TO PRIME THE Q SYTE TRI EXTENSION 385158, NOT ABLE TO PRIME TWO LUMENS DUE TO RESISTANCE IN SEPTUM AND ALSO NOT ABLE TO CONNECT BD POSIFLUSH LUE LOK TO Q SYTE. ONE LUMEN WE CAN ACCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15890738 ↗
• MalfunctionNov 30, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT 3 BD Q-SYTE 15CM SMALL BORE TRI-EXT SETS WERE NOT ABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE USER IS TRYING TO PRIME THE Q SYTE TRI EXTENSION 385158, NOT ABLE TO PRIME TWO LUMENS DUE TO RESISTANCE IN SEPTUM AND NOT ABLE TO CONNECT POSIFLUSH LUE LOK TO Q SYTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15890379 ↗
• MalfunctionNov 29, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED WHILE USING BD Q-SYTE 15CM SMALL BORE TRI-EXT SET THE PACKAGING WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS COMPLAINED TO RDS ON THE DAMAGE OF PACKING OF ONE QUANTITY OF Q SYTE SMALL BORE TRI EXT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15883653 ↗