Q-Syte 385151Recalls & reported problems
Becton, Dickinson And Company · Extension Set 15 cm (6 IN) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Becton Dickinson Q-Syte extension set is used with intravenous lines to deliver fluids or medicines. The 25 reports mainly describe leaks, loose connections or caps, damaged packaging, and occasional breakage or rupture; no deaths or injuries were reported. No recalls name this device, and reports rose to 11 in the latest 12 months from 2 in the previous 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00382903851515), received between Nov 28, 2023 and May 13, 2026 — classified as 25 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (8 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash8
- Loose or Intermittent Connection6
- Material Integrity Problem3
- Break2
- Connection Problem2
- Defective Component2
- Failure to Disconnect2
- Manufacturing, Packaging or Shipping Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Insufficient Information4
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2026Manufacturing, Packaging or Shipping Problem
"IT WAS REPORTED THAT THE PACKAGE WAS DAMAGED AND THAT AIR WAS LEAKING FROM THE PACKAGE. WHILE STORING THE PRODUCTS, THE PACKAGING WAS SQUEEZED, WHAT MADE THEM NOTICE THAT IT REALLY COLLAPSED: AIR WAS LEAVING THE PACKAGE. THEY DID A WATER TEST, AND BUBBLES CAME OUT OF THE PACKAGE. (SEE MOVIE IN EMAIL) WHEN DID THE INCIDENT OCCUR? - BEFORE USE AS ALSO DISCUSSED OVER THE PHONE WITH KIM, WE HAVE THE FOLLOWING SITUATION BEFORE US: AN OKA NURSE SAW HER COLLEAGUE ¿STUFFING¿ BD Q-SYTE REF (B)(4) INTO A DRAWER, PRESSING THE PACKS TOGETHER AND THE AIR ¿DISAPPEARING¿. SHE PUT SOME PACKS ON HER DESK AND THEY SLOWLY FILLED BACK WITH AIR AFTERWARDS (AFTER A FEW HOURS/DAYS: BACK BULGING PACKS). I HELD THAT PACKAGING UNDER WATER AND APPLIED PRESSURE AND AIR BUBBLES EFFECTIVELY CAME THROUGH (SEE VIDEO - LOT 5307254). AFTERWARDS, I WENT TO GET A NEW PACK IN THE ECONOMIZER AND THIS PACK EFFECTIVELY CAME OUT OF THE BOX (OVERPACK), I ALSO SUBMERGED IT IN WATER AND APPLIED LIGHT PRESSURE (SO LESS PRESSURE THAN IN THE VIDEO), AIR BUBBLES CAME OUT HERE TOO. LOT NUMBER 5274103. DOESN'T SEEM OKAY TO ME?".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162651 ↗MalfunctionMay 13, 2026Manufacturing, Packaging or Shipping Problem
"IT WAS REPORTED THAT THE PACKAGE WAS DAMAGED AND THAT AIR WAS LEAKING FROM THE PACKAGE. WHILE STORING THE PRODUCTS, THE PACKAGING WAS SQUEEZED, WHAT MADE THEM NOTICE THAT IT REALLY COLLAPSED: AIR WAS LEAVING THE PACKAGE. THEY DID A WATER TEST, AND BUBBLES CAME OUT OF THE PACKAGE. (SEE MOVIE IN EMAIL) WHEN DID THE INCIDENT OCCUR? - BEFORE USE AS ALSO DISCUSSED OVER THE PHONE WITH KIM, WE HAVE THE FOLLOWING SITUATION BEFORE US: AN OKA NURSE SAW HER COLLEAGUE ¿STUFFING¿ BD Q-SYTE REF 385151 INTO A DRAWER, PRESSING THE PACKS TOGETHER AND THE AIR ¿DISAPPEARING¿. SHE PUT SOME PACKS ON HER DESK AND THEY SLOWLY FILLED BACK WITH AIR AFTERWARDS (AFTER A FEW HOURS/DAYS: BACK BULGING PACKS). I HELD THAT PACKAGING UNDER WATER AND APPLIED PRESSURE AND AIR BUBBLES EFFECTIVELY CAME THROUGH (SEE VIDEO - LOT 5307254). AFTERWARDS, I WENT TO GET A NEW PACK IN THE ECONOMIZER AND THIS PACK EFFECTIVELY CAME OUT OF THE BOX (OVERPACK), I ALSO SUBMERGED IT IN WATER AND APPLIED LIGHT PRESSURE (SO LESS PRESSURE THAN IN THE VIDEO), AIR BUBBLES CAME OUT HERE TOO. LOT NUMBER 5274103. DOESN'T SEEM OKAY TO ME?"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162643 ↗MalfunctionApr 30, 2026Material Integrity Problem
IT WAS REPORTED THAT, OVER THE WEEKEND, THERE WERE TWO INSTANCES IN WHICH THE Q-SYTE SCREW CAP CAME LOOSE FROM THE CANNULA ON ITS OWN IN TWO DIFFERENT PATIENTS. SIMILAR INCIDENTS HAVE ALSO OCCURRED ABOUT FIVE TIMES WITHIN A SHORT PERIOD OF TIME PREVIOUSLY. THE CANNULA REMAINED OPEN WITHOUT PROTECTION, POSING A RISK OF BLEEDING THROUGH THE CANNULA AND A POTENTIAL RISK OF INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25049032 ↗MalfunctionApr 30, 2026Material Integrity Problem
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045760 ↗MalfunctionApr 30, 2026Material Integrity Problem
IT WAS REPORTED THAT, OVER THE WEEKEND, THERE WERE TWO INSTANCES IN WHICH THE Q-SYTE SCREW CAP CAME LOOSE FROM THE CANNULA ON ITS OWN IN TWO DIFFERENT PATIENTS. SIMILAR INCIDENTS HAVE ALSO OCCURRED ABOUT FIVE TIMES WITHIN A SHORT PERIOD OF TIME PREVIOUSLY. THE CANNULA REMAINED OPEN WITHOUT PROTECTION, POSING A RISK OF BLEEDING THROUGH THE CANNULA AND A POTENTIAL RISK OF INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045759 ↗MalfunctionApr 3, 2026Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781037 ↗MalfunctionMar 26, 2026Break
ONE DAY AFTER THE PATIENT WAS PLACED IN THE DEVICE,THE NURSE DISCOVERED IT HAD RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24701105 ↗MalfunctionJan 14, 2026Break
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24075065 ↗MalfunctionJan 5, 2026Disconnection; Leak/Splash
IT WAS REPORTED THAT BD EXT SET 15CM SMALL BORE SPIN NUT SEPARATED AND LEAKED IT WAS REPORTED THAT THE PATIENT HAD A CANNULA WITH A TAILED SPIRAL Q PULSE ATTACHED TO IT. TWO DIFFERENT FLUIDS DRIPPED INTO THE CANNULA THROUGH THE Q-SYTE AT THE SAME TIME. THE CANNULA WAS PUT IN IN THE EVENING AND ITS FUNCTIONALITY WAS CHECKED DURING THE EVENING AND NIGHT AND IT WORKED FLAWLESSLY. AT NIGHT, WHEN WE WENT TO THE ROOM TO TAKE OFF THE SECOND FLUID DRIP AS PLANNED, IT WAS NOTICED THAT THE CANNULA DRESSINGS, THE PATIENT'S SHIRT AND SHEET WERE HEAVILY WET. THE CANNULA WAS PROTECTED WITH GAUZE, SO THE DRESSINGS WERE DISMANTLED AND IT WAS NOTICED THAT THE Q-CYTE HAD COMPLETELY DETACHED FROM THE CANNULA AND THE FLUIDS HAD BEEN ABLE TO LEAK PAST THE CANNULA. AS A RESULT OF THE DETACHMENT OF THE Q-SYTE, THE CANNULA NO LONGER WORKED. AS A RESULT OF THE INCIDENT, THE PATIENT HAD TO BE WOKEN UP AT NIGHT AND THE CANNULA REMOVED, AS WELL AS CHANGE INTO DRY CLOTHES AND BED SHEETS. HOWEVER, THE CANNULA DID NOT HAVE TO BE REPLACED DURING THE NIGHT, AS ENOUGH FLUIDS HAD ALREADY BEEN EMITTED. DESCRIPTION OF THE CONSEQUENCE OF THE INCIDENT OR A POSSIBLE CONSEQUENCE FOR THE PATIENT/CLIENT OR OTHER PERSON DELA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23960619 ↗MalfunctionDec 31, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem
IT WAS REPORTED THAT BD EXT SET 15CM SMALL BORE SPIN NUT HAD CONNECTION ISSUES AND LEAKED IT WAS REPORTED WHEN CONNECTING TO THE CATHETER, THE Q-SYTE UNSCREWS BY ITSELF, CAUSING LEAKS. WHEN DID THE INCIDENT OCCUR? DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23934772 ↗MalfunctionDec 31, 2025Leak/Splash; Connection Problem; Leak/Splash; Connection Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23934764 ↗MalfunctionNov 25, 2024Failure to Disconnect; Failure to Disconnect
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20775232 ↗MalfunctionNov 25, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20773244 ↗MalfunctionOct 28, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20551986 ↗MalfunctionOct 28, 2024Loose or Intermittent Connection; Failure to Disconnect; Loose or Intermittent Connection; Failure to Disconnect
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20551422 ↗MalfunctionOct 3, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20359981 ↗MalfunctionSep 16, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20229414 ↗MalfunctionApr 16, 2024Packaging Problem; Packaging Problem
PLEASE ALSO PROVIDE US WITH THE FULL PICKUP ADDRESS, CONTACT NAME AND NUMBER, DEPARTMENT NAME, FLOOR NUMBER, AND ANY ADDITIONAL DETAILS SUCH AS (PICK UP AT RECEPTION, GOODS IN YARD, ETC.) AND WE WILL SCHEDULE SAMPLE PICK-UP REQUEST FOR YOU USING TNT CARRIER. CONTACT (B)(6). PHONE (B)(6). (B)(6) HOSPITAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19121909 ↗MalfunctionMar 1, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD EXT SET 15CM SMALL BORE SPIN NUT LEAKED IT WAS REPORTED BY THE CUSTOMER THAT LEAKING OF Q SITE CONNECTED TO PICC LINE ON NEONATE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. LEAKING OF Q SITE CONNECTED TO PICC LINE ON NEONATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18819895 ↗MalfunctionFeb 16, 2024Defective Component; Defective Component
IT WAS REPORTED THAT BD EXT SET 15CM SMALL BORE SPIN NUT SEPTUM IS NOT PROPERLY ADHERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OUR NICU HAS REPORTED 2 DIFFERENT INSTANCES OF LEAKING Q-SYTE AT THE CONNECTION. IT APPEARS THAT THE RUBBER ON THE END OF Q-SYTE IS NOT PROPERLY ADHERED CAUSING A LEAK FROM THE SIDE OF THE RUBBER CONNECTION. I HAVE BOTH SAMPLES AVAILABLE IF NEEDED.
Patient problems: Insufficient Information
MAUDE report 18719752 ↗MalfunctionFeb 16, 2024Defective Component; Defective Component
FOLLOW UP: 1. PLEASE PROVIDE THE DATE OF EVENT. ¿ FIRST EVENT WAS 1-15-24; SECOND EVENT WAS 1-28-24 2. IS THERE ANY SAMPLE AVAILABLE? ¿ YES, BOTH SAMPLES ARE AVAILABLE. ADDITIONAL INFORMATION RECEIVED ON 01-APR-2024 FOR EACH EVENT, THE PRODUCT WAS SWITCHED TO A NEW PRODUCT UNTIL THEY FOUND ONE THAT DIDN¿T LEAK. THERE WAS NO HARM TO ANY PATIENTS. I HAVE THE SHIPPING LABEL AND WILL SEND THAT OUT TODAY.
Patient problems: Insufficient Information
MAUDE report 18719750 ↗MalfunctionJan 29, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18596376 ↗MalfunctionDec 18, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD EXT SET 15CM SMALL BORE SPIN NUT LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; DEAR PARTNER, I AM SENDING NEW COMPLAINT FORM FOR PRODUCT WITH REF:(B)(4). THE COMPLAINT WAS FILED BY THE (B)(6) HOSPITAL AGAIN AS THEY DON'T AGREE WITH CLOSURE OF COMPLAINT INVESTIGATION REPORT :NUMBER: (B)(4). WOULD YOU BE SO KIND AND NOTICE US HOW TO PROCEED. THE HOSPITAL PHARMACY HAS RECEIVED MULTIPLE COMPLAINTS REGARDING PRODUCT 385151 (Q-SYTE EXT.SET MICRO 6" A50) WITH THE EXPLANATION THAT THEY HAVE DETECTED LEAKAGE AT THE POINT WHERE THE TUBE OF THE EXT.SET CONNECTS TO THE LUER LOCK CONNECTOR MADE OF A HARDER PLASTIC (ON THE IV CANNULA SITE). WHEN INJECTED WITH SLIGHTLY GREATER FORCE OR SPEED, AND/OR IF THE INFUSION CONTINUED FOR AN EXTENDED PERIOD, A DROPLET OF LIQUID APPEARED AT THE POINT BETWEEN THE TUBE AND THE PLASTIC LUER LOCK CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18346812 ↗MalfunctionNov 29, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT BD EXT SET 15CM SMALL BORE SPIN NUT HAD A LOOSE COMPONENT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; "NOTE THAT WE HAVE SENT SIMILAR COMPLAINTS OF THIS PRODUCT BEFORE, FROM DIFFERENT HOSPITAL. THE SCREW THREAT DOES NOT FIT, IT OPENS EASILY. ON THE OTHER HAND THE TUBE ATTACHES VERY TIGHTLY INTO IV.-CANNULA (CLIP NEO), AND WILL NOT GET LOOSE/CANNOT BE CHANGED. THIS IS A BIG RISK FOR THE IV-CANNULA TO GET LOOSE, ESPECIALLY WITH NEONATES AND PREMATURE BABIES."
Patient problems: Insufficient Information
MAUDE report 18229616 ↗MalfunctionNov 28, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT BD EXT SET 15CM SMALL BORE SPIN NUT HAD LOOSE COMPONENT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; THE SCREW THREAT DOES NOT FIT, IT OPENS EASILY. ON THE OTHER HAND THE TUBE ATTACHES VERY TIGHTLY INTO IV.-CANNULA (CLIP NEO), AND WILL NOT GET LOOSE/CANNOT BE CHANGED. THIS IS A BIG RISK FOR THE IV-CANNULA TO GET LOOSE, ESPECIALLY WITH NEONATES AND PREMATURE BABIES. EVENT OCCURRED DURING USE.
Patient problems: Insufficient Information
MAUDE report 18222476 ↗
Other Set, administration, intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page