BD SmartSite 2300E-0500Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10885403235023), received between Sep 16, 2019 and Feb 5, 2026 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT THE BD ALARIS BAG ACCESS DEVICE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED MULTIPLE OCCURRENCES OF SKU # 2300E-0500 BREAKING WHERE THE CONNECTOR ATTACHED TO THE SPIKE. THE SPIKE BROKE WHERE THE LUER LOCK PIECE ATTACHES. IT LOOKS LIKE THE TOP WAS LOOSE AND HAD POPPED OFF. NURSE HAD BEEN SPIKING A REGULAR IV FLUID BAG AS USUAL WITHOUT ANY ROUGH FORCE AND THE TOP POPPED RIGHT OFF. LOT # 25105146 EXP 10/5/28 NUMBER OF AFFECTED UNITS OF (B)(6) CLINIC HAS 3 FULL CASES WERE THERE ANY ADVERSE EFFECTS TO STAFF AND/OR PATIENTS? THE ONLY ADVERSE EFFECTS WAS A ZIRABEV DOSAGE HAVING TO BE REMADE, BUT A REPLACEMENT HAD ALREADY BEEN SENT AND RECEIVED IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272547 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT THE BD ALARIS BAG ACCESS DEVICE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED MULTIPLE OCCURRENCES OF SKU# 2300E-0500 BREAKING WHERE THE CONNECTOR ATTACHED TO THE SPIKE. THE SPIKE BROKE WHERE THE LUER LOCK PIECE ATTACHES. IT LOOKS LIKE THE TOP WAS LOOSE AND HAD POPPED OFF. NURSE HAD BEEN SPIKING A REGULAR IV FLUID BAG AS USUAL WITHOUT ANY ROUGH FORCE AND THE TOP POPPED RIGHT OFF. LOT# 25105146 EXP 10/5/28 NUMBER OF AFFECTED UNITS OF (B)(4) CLINIC HAS 3 FULL CASES WERE THERE ANY ADVERSE EFFECTS TO STAFF AND/OR PATIENTS? THE ONLY ADVERSE EFFECTS WAS A (B)(6) DOSAGE HAVING TO BE REMADE, BUT A REPLACEMENT HAD ALREADY BEEN SENT AND RECEIVED IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272506 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT THE BD ALARIS BAG ACCESS DEVICE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED MULTIPLE OCCURRENCES OF SKU#: 2300E-0500 BREAKING WHERE THE CONNECTOR ATTACHED TO THE SPIKE. THE SPIKE BROKE WHERE THE LUER LOCK PIECE ATTACHES. IT LOOKS LIKE THE TOP WAS LOOSE AND HAD POPPED OFF. NURSE HAD BEEN SPIKING A REGULAR IV FLUID BAG AS USUAL WITHOUT ANY ROUGH FORCE AND THE TOP POPPED RIGHT OFF. LOT#: 25105146 EXP 10/5/2028. NUMBER OF AFFECTED UNITS OF 2300E-0500 CLINIC HAS 3 FULL CASES. WERE THERE ANY ADVERSE EFFECTS TO STAFF AND/OR PATIENTS? THE ONLY ADVERSE EFFECTS WAS A ZIRABEV DOSAGE HAVING TO BE REMADE, BUT A REPLACEMENT HAD ALREADY BEEN SENT AND RECEIVED IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272449 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT BD SMARTSITE BAG ACCESS DEVICE WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT WHILE USING THE PRODUCT TOWARDS THE END OF STERILE COMPOUNDING, THERE WERE TWO OCCURRENCES OF SPIKES BREAKING FROM THE LUER LOCK CONNECTION CAUSING MEDICATION TO LEAK ONTO THE WORK SURFACE OF THE COMPOUNDING HOOD. THE THIRD SPIKE BROKE DURING THE BEGINNING OF STERILE COMPOUNDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23538371 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT BD SMARTSITE BAG ACCESS DEVICE WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT WHILE USING THE PRODUCT TOWARDS THE END OF STERILE COMPOUNDING, THERE WERE TWO OCCURRENCES OF SPIKES BREAKING FROM THE LUER LOCK CONNECTION CAUSING MEDICATION TO LEAK ONTO THE WORK SURFACE OF THE COMPOUNDING HOOD. THE THIRD SPIKE BROKE DURING THE BEGINNING OF STERILE COMPOUNDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23538367 ↗
• MalfunctionNov 12, 2025Break; Break

  IT WAS REPORTED THAT BD SMARTSITE BAG ACCESS DEVICE WAS DAMAGED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT WHILE USING THE PRODUCT TOWARDS THE END OF STERILE COMPOUNDING, THERE WERE TWO OCCURRENCES OF SPIKES BREAKING FROM THE LUER LOCK CONNECTION CAUSING MEDICATION TO LEAK ONTO THE WORK SURFACE OF THE COMPOUNDING HOOD. THE THIRD SPIKE BROKE DURING THE BEGINNING OF STERILE COMPOUNDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23538363 ↗
• MalfunctionSep 2, 2025Leak/Splash; Activation, Positioning or Separation Problem; Leak/Splash; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT BD ALARIS CLOSED MALE LUER WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT THE SMARTSITE BAG ACCESS DEVICE WAS LEAKING AT THE CONNECTION POINT WHERE THE BAG WAS SPIKED. THE NURSE LATER REPORTED THAT THE DEVICE HAD DISLODGED FROM THE BAG, RESULTING IN A CHEMOTHERAPY SPILL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22948637 ↗
• MalfunctionJun 22, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SMARTSITE BAG ACCESS DEVICE WAS LEAKING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER, COUPLER LEAKING DURING WHILE IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22304621 ↗
• MalfunctionJun 9, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE BAG ACCESS DEVICE HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE¿VE BEEN HAVING SOME ISSUES WITH SEVERAL OF THE BD NEEDLELESS COUPLERS (SMARTSITE BAG ACCESS DEVICE) LEAKING. THE LEAKS HAVE ALL BEEN FROM THE SAME LOT AND HAVE OCCURRED IN THE SAME PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22172711 ↗
• MalfunctionApr 28, 2025Break; Break

  IT WAS REPORTED THAT BD ALARIS SMARTSITE BAG ACCESS DEVICE BREAKS THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT SMARTSITE BAG ACCESS DEVICE PORT BREAKS OFF WHILE ATTACHING SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919612 ↗
• MalfunctionMar 6, 2025Break; Break

  IT WAS REPORTED THAT BD ALARIS SMARTSITE BAG ACCESS DEVICE WAS BROKEN. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT THE SPIKE BROKE OFF FROM THE ACCESS POINT AFTER THE BLOOD BAG WAS SPIKED. BROKEN PIECE IN BAG WITH INTACT PIECE FOR REFERENCE. ONCE BROKEN, SPILLED BLOOD AND COULD NOT GET OUT OF SPIKE PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21543524 ↗
• MalfunctionNov 27, 2024Break; Break

  MATERIALS: 2300E-0500 BATCH#: 24025033. IT WAS REPORTED BY THE CUSTOMER THAT "CRACKED LUER LOCK." RCC RECEIVED A COMPLAINT VIA EMAIL. CHC COMPLAINT REFERENCE #:(B)(4), HOSPITAL COMPLAINT REFERENCE #: (B)(4), CUSTOMER (HOSPITAL) NAME: XX XXXX XXXX - XXXXX XXXX, CUSTOMER ADDRESS: XXX XXX XXX X XXXXXX - XXX XXXX, XXXX, XX, XXXX, (B)(6), CONTACT NAME: XXX XX XX, PHONE: XXXXXXXXXX(EXT: XXX), E-MAIL: [email protected]. CORRESPONDENCE LANGUAGE: ENGLISH, CAT# OF PRODUCT BEING COMPLAINED: (B)(4), DESCRIPTION OF PRODUCT: BAG ACCESS DEVICE 100EA/CA, LOT OR S/N: (B)(6), COMPLAINT CATEGORY: DAMAGED / BROKEN, REPORTABLE: NO, INCIDENT DATE: (B)(6) 2024, HOSPITAL COMPLAINT REFERENCE #:(B)(4), DETAILS OF COMPLAINT (REPORTED ISSUE): "CRACKED LUER LOCK," COMPLAINT NOTICED: DURING / AFTER USE, PROBLEM FREQUENCY: 1ST TIME. CUSTOMER EXPOSURE: PATIENT INJURY: NO HAS HEALTH CANADA BEEN INFORMED? UNKNOWN QTY AFFECTED: 2 EA SAMPLES AVAILABLE? NO IS CUSTOMER REQUESTING AN RGA?: NO RETURN QTY:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798126 ↗
• MalfunctionOct 20, 2024Defective Component; Defective Component

  MATERIAL: 2300E-0500, BATCH#: 24075033, 24075038. IT WAS REPORTED BY THE CUSTOMER THAT HAVE BEEN AT LEAST 14 OCCURRENCES OF THE SMARTSITE CONNECTOR IS BREAKING OFF OF THE BAG SPIKE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. THERE HAVE BEEN AT LEAST 14 OCCURRENCES OF THE SMARTSITE CONNECTOR IS BREAKING OFF OF THE BAG SPIKE. THE CUSTOMER HAS INCLUDED PICTURES AND THEY'RE IN THE EMAIL STRING I'VE SENT WITH THIS FORM. I HAVE ALSO INQUIRED IF THEY'VE RETAINED ANY SAMPLES AND WILL LET YOU KNOW IF A RETURN KIT NEEDS TO BE SENT. PRODUCT#: 2300E-0500, LOT#: 24075033 AND 24075038. THIS IS A FOLLOW UP TO THE COMPLAINT I FILED YESTERDAY. THE CUSTOMER HAS RETAINED AN AFFECTED SAMPLE FOR RETURN TO BD. PLEASE CONFIRM WHEN YOU SEND THE RETURN KIT SO I CAN INFORM THE CUSTOMER, BELOW IS THE SHIP-TO INFO: XXXX. WE HAD ONE OCCURRENCE ON (B)(6) 2024. I DO HAVE A SAMPLE TO SEND BACK FOR INVESTIGATION. NO REPORTS WERE REPORTED OF INJURY TO THE PATIENT OR THE HEALTHCARE PROVIDER. THE SAMPLE WE HAVE IS FROM LOT # 24075038. LET ME KNOW IF YOU NEED ANY ADDITIONAL INFORMATION. (B)(6) DID SEND OUT THE DEFECTIVE SPIKE AND WAS DELIVERED TO (B)(6). (B)(6) SENT PICTURES OF THE SPIKE RECEIVED. WE ONLY HAD ONE D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490185 ↗
• MalfunctionApr 9, 2024Break; Break

  IT WAS REPORTED THAT BD ALARIS SMARTSITE BAG ACCESS DEVICE WAS BROKEN THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM THE SMARTSITE CONNECTOR IS BREAKING OFF OF THE BAG SPIKE. THE CUSTOMER HAS RETAINED AFFECTED SAMPLES, ALSO HAS A PICTURE. THEY HAVE 12 CASES OF PRODUCT WITH THE SAME LOT# THAT NEED TO BE RETURNED AND REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 19072864 ↗
• MalfunctionOct 9, 2023Break; Break

  IT WAS REPORTED THAT THE SMARTSITE¿ BAG SPIKE, PRIMING VOLUME 0.5 ML DAMAGED, BREAKING. 2 OF 2 RELATED FILES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOME ARE ALSO BREAKING.

  Patient problems: Insufficient Information

  MAUDE report 17896048 ↗
• MalfunctionOct 5, 2023Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION. IT WAS REPORTED THAT THE SMARTSITE¿ BAG SPIKE, PRIMING VOLUME 0.5 ML EXPERIENCED LEAKAGE. 1 OF 2 RELATED FILES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED MULTIPLE OCCURRENCES OF LEAKING WITH SKU# 2300E-0500.

  Patient problems: Insufficient Information

  MAUDE report 17882566 ↗
• MalfunctionNov 14, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD SMARTSITE¿ BAG SPIKE, PRIMING VOLUME 0.5 ML LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEVICE APPEARS TO BE LEAKING AFTER CONNECTOR IS APPLIED. MULTIPLE OCCURRENCES OF LEAKING WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15792700 ↗
• MalfunctionNov 14, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD SMARTSITE¿ BAG SPIKE, PRIMING VOLUME 0.5 ML LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEVICE APPEARS TO BE LEAKING AFTER CONNECTOR IS APPLIED. MULTIPLE OCCURRENCES OF LEAKING WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15792649 ↗
• MalfunctionSep 22, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BAG ACCESS DEVICE SPIKE WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 2300E-0500, BATCH NO.: 20025450, UNKNOWN (PROVIDED: 200438A, 2004488). IT WAS REPORTED THE SPIKE IS SNAPPING OFF AT THE POINT OF THE CLEAR LUER LOCK MECHANISM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10570916 ↗
• MalfunctionJun 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE SMARTSITE ACCESS DEVICE SEPARATED FROM THE SPIKE. THIS IS THE FIRST TIME THIS HAPPENED WITH THIS SAME LOT OF PRODUCT. THE CUSTOMER HAS ASKED WHETHER THE DEVICE IS GLUED TOGETHER OR HELD BY FRICTION. THERE WAS NO PATIENT INVOLVEMENT NOR ADVERSE CONSEQUENCE RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10109274 ↗
• MalfunctionMay 20, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE SMARTSITE ACCESS DEVICE SEPARATED FROM THE SPIKE. THIS IS THE SECOND TIME THIS HAPPENED WITH THIS SAME LOT OF PRODUCT. THE CUSTOMER HAS ASKED WHETHER THE DEVICE IS GLUED TOGETHER OR HELD BY FRICTION. THERE WAS NO PATIENT INVOLVEMENT NOR ADVERSE CONSEQUENCE RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10074809 ↗
• MalfunctionMay 20, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE SMARTSITE ACCESS DEVICE SEPARATED FROM THE SPIKE. THIS IS THE SECOND TIME THIS HAPPENED WITH THIS SAME LOT OF PRODUCT. THE CUSTOMER HAS ASKED WHETHER THE DEVICE IS GLUED TOGETHER OR HELD BY FRICTION. THERE WAS NO PATIENT INVOLVEMENT NOR ADVERSE CONSEQUENCE RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10074768 ↗
• MalfunctionJan 27, 2020Disconnection; Disconnection

  IT WAS REPORTED FROM THE OPERATING ROOM (OR) THAT THE BAG ACCESS DEVICE CLEAR MALE CONNECTOR IS COMING OFF OF THE WHITE BARREL. A FEW ANESTHESIA PROVIDERS WERE POTENTIALLY EXPOSED TO MEDICATIONS, INCLUDING EPINEPHRINE, DOPAMINE, AND MILRINONE. THIS WOULD BE SKIN EXPOSURE, NO MUCOUS MEMBRANE EXPOSURE REPORTED. THE CUSTOMER FURTHER STATED GIVEN THE NATURE OF THEIR USE OF THE PRODUCT , NO PATIENT EXPOSURE IS EXPECTED. DELAYS IN PATIENT TREATMENT POSSIBLE, AS PROVIDER WOULD NEED TO FIND ALTERNATIVE EQUIPMENT FOR DRAWING UP MEDICATION FROM THE BAG. ALSO POTENTIAL PROVIDER EXPOSURE TO MEDICATIONS WHEN THE BAG CONTENTS LEAKS OUT. THERE WAS NO HARM TO PATIENT ON THIS PARTICULAR FAILURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9631863 ↗
• MalfunctionJan 27, 2020Disconnection; Disconnection

  IT WAS REPORTED FROM THE OPERATING ROOM (OR) THAT THE BAG ACCESS DEVICE CLEAR MALE CONNECTOR IS COMING OFF OF THE WHITE BARREL. A FEW ANESTHESIA PROVIDERS WERE POTENTIALLY EXPOSED TO MEDICATIONS, INCLUDING EPINEPHRINE, DOPAMINE, AND MILRINONE. THIS WOULD BE SKIN EXPOSURE, NO MUCOUS MEMBRANE EXPOSURE REPORTED. THE CUSTOMER FURTHER STATED GIVEN THE NATURE OF THEIR USE OF THE PRODUCT , NO PATIENT EXPOSURE IS EXPECTED. DELAYS IN PATIENT TREATMENT POSSIBLE, AS PROVIDER WOULD NEED TO FIND ALTERNATIVE EQUIPMENT FOR DRAWING UP MEDICATION FROM THE BAG. ALSO POTENTIAL PROVIDER EXPOSURE TO MEDICATIONS WHEN THE BAG CONTENTS LEAKS OUT. THERE WAS NO HARM TO PATIENT ON THIS PARTICULAR FAILURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9631860 ↗
• MalfunctionJan 27, 2020Disconnection; Disconnection

  IT WAS REPORTED FROM THE OPERATING ROOM THAT THE BAG ACCESS DEVICE CLEAR MALE CONNECTOR IS COMING OFF OF THE WHITE BARREL. A FEW ANESTHESIA PROVIDERS WERE POTENTIALLY EXPOSED TO MEDICATIONS, INCLUDING EPINEPHRINE, DOPAMINE, AND MILRINONE. THIS WOULD BE SKIN EXPOSURE, NO MUCOUS MEMBRANE EXPOSURE REPORTED. THE CUSTOMER FURTHER STATED GIVEN THE NATURE OF THEIR USE OF THE PRODUCT, NO PATIENT EXPOSURE IS EXPECTED. DELAYS IN PATIENT TREATMENT POSSIBLE, AS PROVIDER WOULD NEED TO FIND ALTERNATIVE EQUIPMENT FOR DRAWING UP MEDICATION FROM THE BAG. ALSO POTENTIAL PROVIDER EXPOSURE TO MEDICATIONS WHEN THE BAG CONTENTS LEAKS OUT. THERE WAS NO HARM TO PATIENT ON THIS PARTICULAR FAILURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9631753 ↗