BD Q-Syte 385108Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00382903851089), received between Jan 25, 2019 and Aug 23, 2024 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 reports).

11 other recalls cover devices cleared under the same FDA submission (K013621); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 23, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20057026 ↗
• MalfunctionAug 22, 2024Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043799 ↗
• MalfunctionApr 1, 2024Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT BD Q-SYTE VIAL ACCESS ADAPTER EXPIRATION LABEL WAS INCORRECT. IT WAS REPORTED BY CUSTOMER THAT ONE EXPIRATION DATE ON THE OUTSIDE BOX AND A DIFFERENT EXP. DATE ON THE INSIDE OF THE PACKAGES. 35 CASES 140 BOXES TOTAL VERBATIM#: CUSTOMER RECEIVED WITH ONE EXPIRATION DATE ON THE OUTSIDE BOX AND A DIFFERENT EXP. DATE ON THE INSIDE OF THE PACKAGES. 35 CASES 140 BOXES TOTAL REPLY: DID THE PRODUCT USED ON THE PATIENT. IF YES, PLEASE DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED BECAUSE OF THE EVENT.-NO. · PLEASE SHARE THE CAPTURED PHOTO OF THE EVENT IF AVAILABLE.PICTURE IS ATTACHED. · PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL.-CUSTOMER RECEIVED PRODUCT AT A FEW FACILITIES, WE ARE HAVING ALL THE AFFECTED PRODUCT RETURNED BACK TO OUR WAREHOUSES. · PLEASE CONFIRM WHETHER BOTH EXPIRATION IS BEYOND/WITHIN THE SHELF LIFE.-THE EXPIRATION DATE PRINTED ON THE PACKAGES SHOW 10/31/2008 AND ON THE BOX THE EXP DATE IS 10/31/2028.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19012548 ↗
• MalfunctionMar 25, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ACK SEND A FOLLOW UP FOR ADDITIONAL QUESTIONS: 1. KINDLY PROVIDE THE DATE OF EVENT. 2. CAN YOU SHARE ANY PHYSICAL SAMPLE OR PHOTO IF AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. 1. 1. (B)(6) 2024 2. (B)(6) 3. 3. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968854 ↗
• MalfunctionMar 23, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ACK SEND A FOLLOW UP FOR ADDITIONAL QUESTIONS: 1. KINDLY PROVIDE THE DATE OF EVENT. 2. CAN YOU SHARE ANY PHYSICAL SAMPLE OR PHOTO IF AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. 1.(B)(6) 2024 2. (B)(6) 3.NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965356 ↗
• MalfunctionMar 23, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ACK SEND A FOLLOW UP FOR ADDITIONAL QUESTIONS: 1. KINDLY PROVIDE THE DATE OF EVENT. 2. CAN YOU SHARE ANY PHYSICAL SAMPLE OR PHOTO IF AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. 1. 2/28/2024 2. (B)(6). 3. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18965333 ↗
• MalfunctionMar 22, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BD Q-SYTE VIAL ACCESS ADAPTER EXPIRATION DATES WERE LABELED INCORRECTLY THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT ENSURE IF THEY ARE SHIPPED LOCALLY THE INTERNAL EXPIRATION DATE IS CHECKED ON ALL PRODUCT 2. AT A MINIMUM WE NEED AN RA FROM BD FOR THE PRODUCT WE¿VE IDENTIFIED WHERE THE EXPIRATION ON THE INDIVIDUAL PACKAGING DOES NOT MATCH THE EXPIRATION ON THE BOX. OUR FULFILLMENT TEAM FOUND VIAL ADAPTERS ((B)(6) INVENTORY ID (B)(4) / MCKESSON # (B)(4) ) UNDER LOT # 3333847 WITH THE EXPIRATION DATE OF 10/31/2008, BUT THE OUTER BOX HAS THE EXPIRATION DATE OF 10/31/2028. UNDER THE SAME LOT #, THERE IS ALSO PRODUCT WITH THE EXPIRATION DATE OF 10/31/2028. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ENSURE IF THEY ARE SHIPPED LOCALLY THE INTERNAL EXPIRATION DATE IS CHECKED ON ALL PRODUCT 2. AT A MINIMUM WE NEED AN RA FROM BD FOR THE PRODUCT WE¿VE IDENTIFIED WHERE THE EXPIRATION ON THE INDIVIDUAL PACKAGING DOES NOT MATCH THE EXPIRATION ON THE BOX. OUR FULFILLMENT TEAM FOUND VIAL ADAPTERS ((B)(6) INVENTORY ID (B)(4) / MCKESSON # (B)(4) ) UNDER LOT # 3333847 WITH THE EXPIRATION DATE OF 10/31/2008, BUT THE OUTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960966 ↗
• MalfunctionMar 22, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ACK SEND A FOLLOW UP FOR ADDITIONAL QUESTIONS: 1. KINDLY PROVIDE THE DATE OF EVENT. 2. CAN YOU SHARE ANY PHYSICAL SAMPLE OR PHOTO IF AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. 1. 2/28/2024 2. (B)(6). 3. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960965 ↗
• MalfunctionNov 22, 2023Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18194275 ↗
• MalfunctionJul 18, 2023Leak/Splash; Defective Component; Leak/Splash; Defective Component

  IT WAS REPORTED THAT DURING USE WITH BD Q-SYTE¿ VIAL ACCESS ADAPTER THE ADAPTER WAS DAMAGED AND LEAKAGE OCCURRED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PT ADVISED SHE HAS HAD MULTIPLE DEFECTIVE ADAPTERS THAT HAVEN'T CLICKED ONTO THE VIAL AND HAVE CAUSED LEAKING AND WASTING OF CASSETTES. PT WANTED TO KNOW IF THIS WAS SOMETHING WE HAD NOTICED WITH PATIENTS RECENTLY. NO MISSED DOSES OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17346815 ↗
• MalfunctionDec 2, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT YELLOWISH FOREIGN MATTER WAS FOUND INSIDE THE MIDDLE CHAMBER OF THE BD Q-SYTE¿ VIAL ACCESS ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT HAS BEEN NOTED TO HAVE A YELLOWISH SUBSTANCE IN ONE OF THE CHAMBERS ( MIDDLE CHAMBER ) IN THIS PRODUCT . IT WAS REPORTED BY A CO-WORKER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15902251 ↗
• MalfunctionApr 19, 2022Partial Blockage; Leak/Splash; Air/Gas in Device; Partial Blockage; Leak/Splash; Air/Gas in Device

  IT WAS REPORTED THAT THE BD Q-SYTE VIAL ACCESS ADAPTER EXPERIENCED LEAKAGE AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE FROM THE INSERTION SITE IN THE VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14142006 ↗
• MalfunctionMar 24, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD Q-SYTE¿ VIAL ACCESS ADAPTER LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE VIAL LEAKED OUT MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13893578 ↗
• MalfunctionDec 1, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED BD Q-SYTE VIAL ACCESS ADAPTER HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT REPORTED THAT WHILE SHE WAS MIXING HER CASSETTE FOR IV VELETRI, ONE OF THE Q-SYTE VIAL ADAPTERS LEAKED..."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12914091 ↗
• MalfunctionOct 29, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD Q-SYTE VIAL ACCESS ADAPTER LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENT SAID THAT THE LAST TIME SHE RECEIVED VIAL ADAPTER Q-STYLE FROM OUR PHARMACY THE ADAPTERS LEAKED EVERY TIME SHE INSERTED THEM INTO THE VELETRI VIAL AND WOULD TUM THE VIAL UPSIDE DOWN TO DRAW THE MEDICATION OUT OF THE VIAL. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12720901 ↗
• MalfunctionApr 21, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD Q-SYTE¿ VIAL ACCESS ADAPTER LEAKED REMOULDING DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SOLICITED. PER MOTHER, SOMETIMES SHE LOOSES SOME REMOULDING LEAKING THROUGH THE ADAPTER. (PATIENT ALWAYS RECEIVED THE FULL DOSE. SOME REMOULDING IS BEING WASTED DUE TO THE LEAKING.) SHE IS USING UNIVERSAL VIAL ADAPTER QSYTE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703723 ↗
• MalfunctionJan 23, 2020Leak/Splash; Leak/Splash

  IT HAS BEEN REPORTED THAT THE BD Q-SYTE VIAL ACCESS ADAPTER HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 385108 BATCH NO: UNKNOWN. IT WAS REPORTED THAT WHEN THE PATIENT SPIKES THE VIAL, SOMETIMES THE STOPPER WILL GET A SLIT WHICH HAS RESULTED IN REMOUDULIN TO LEAK. EVENT DESCRIPTION STATES: PATIENT REPORTS THAT WHEN SHE SPIKED HER VIALS SOMETIMES THE STOPPER WILL GET A SLIT AND REMODULIN WILL LEAK OUT (DATES UNKNOWN). PATIENT ALSO REPORTS CURRENTLY EXPERIENCING RED MARKS ON THE BRIDGE OF HER NOSE AND ALONG THE CREASES BY HER MOUTH. INDICATION: PULMONARY ARTERIAL HYPERTENSION (PAH). NO ADDITIONAL ADVERSE EVENTS OR SIDE EFFECTS WERE MENTIONED BY PATIENT DUE TO PRODUCT ISSUE. LOT AND EXPIRATION DATE ARE UNKNOWN. UNKNOWN IF PATIENT STILL HAS PRODUCT ON HAND. MEDWATCH REPORT# MW5091522 WAS FILED IN RESPONSE TO THIS EVENT.

  Patient problems: Skin Discoloration

  MAUDE report 9622029 ↗
• MalfunctionJan 25, 2019Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A BD Q-SYTE¿ VIAL ACCESS ADAPTER HAD A GLUE LIKE RESIDUE WHERE THE NEEDLE CONNECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8279738 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013621. One submission often covers many models, so check the product and lot details in each record.

• Z-1317-2015 · Feb 19, 2015 · Terminated
  BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. An accessory to an intravascular a
• Z-1075-2010 · Nov 6, 2009 · Terminated
  Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.
• Z-1073-2010 · Nov 6, 2009 · Terminated
  Medical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #385151), Part number: 69946B.
• Z-1074-2010 · Nov 6, 2009 · Terminated
  Medical Action Industries, Venous Access Tray, using BD Q-Syte Luer Access Split Septum (BD #385100)), Part number: 69498.
• Z-0753-2010 · Oct 19, 2009 · Terminated
  BD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108, Becton Dickinson Infusion Therapy Systems Inc.
• Z-0751-2010 · Oct 19, 2009 · Terminated
  BD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok, REF 385101, Becton Dickinson Infusion Therapy Systems Inc.
• Z-0755-2010 · Oct 19, 2009 · Terminated
  MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151
• Z-0752-2010 · Oct 19, 2009 · Terminated
  BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, REF 385102, Becton Dickinson Infusion Therapy Systems Inc.
• Z-0750-2010 · Oct 19, 2009 · Terminated
  BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, Becton Dickinson Infusion Therapy Systems Inc.
• Z-0754-2010 · Oct 19, 2009 · Terminated
  MPS Acacia Extension Set, 15cm RightBore-18, Spin Nut w/BBD Q-Syte, REF 385150,
• Z-0756-2010 · Oct 19, 2009 · Terminated
  MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164