BD SmartSite 10798696Recalls & reported problems
BD Switzerland Sàrl · Syringe Administration Set, Microbore Tubing segments, 0.2 Micron Low Protein Binding Filter, Check Valve, Anti-siphon Valve, Needle-Free Valve, Pressure Sensing Disk, Vented/Nonvented, 244 cm (96 in) · Class 2
All models of BD SmartSite (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD SmartSite syringe administration set is a needle-free IV tubing set with a 0.2 micron filter used to deliver medications and nutrition by infusion. The 32 reports mostly describe fluid or blood leaking from the tubing and filter, along with cracked components; a few mention tubing that would not prime or was blocked. No deaths were reported and 2 injuries were reported. One recall began in February 2019 over leaking that could interrupt infusion or contaminate the fluid path, and it is closed.
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
- 32
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10885403234354), received between Oct 16, 2018 and Aug 24, 2020 — classified as 2 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (29 reports).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Feb 28, 2019Class ITerminated
Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates.
Z-1210-2019 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak29
- Crack20
- Complete Blockage2
- Leak/Splash2
- Restricted Flow rate2
- Device Contamination with Chemical or Other Material1
- Obstruction of Flow1
Patient problems
- No Consequences Or Impact To Patient29
- No Patient Involvement3
- No Information1
- Unspecified Infection1
- Venipuncture1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2020Leak/Splash; Device Contamination with Chemical or Other Material; Leak/Splash; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AS SYR PSD ASV 20D SMBORE SS 0.2M CV PLUNGER DETACHED FROM THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 10798696, BATCH NO: 19045397. IT WAS REPORTED THAT THE PLUNGER HAD DETACHED FROM THE SYRINGE. ADDITIONAL INFORMATION (CUSTOMER RESPONSE) 11-AUG-2020: WHAT IS THE DATE THE REPORTED DEFECT HAPPENED? (B)(6) 2020. ARE THE PRODUCTS INVOLVED IN THE EVENT AVAILABLE FOR INVESTIGATIONAL PURPOSES? NO THEY WERE DISCARDED. WAS THE TUBING SET ATTACHED TO A PATIENT AT THE TIME OF THE EVENT OR OCCURRED DURING PREPARATION/PRIMING? OCCURRED DURING PREPARATION. WERE THERE ANY ADVERSE EVENT(S) AS A RESULT OF THE REPORTED DEFECT? IF YES, PLEASE PROVIDE DETAILS NO HARM TO PATIENT. DESCRIBE THE EVENT OR PROBLEM INFANT PATIENT HAD A VERSED DRIP INFUSING THE BAG TO SYRINGE CLOSED SYSTEM. WHEN THE NURSE WENT TO REFILL THE SYRINGE, THE PLUNGER HAD DETACHED FROM THE SYRINGE THERE WAS NO HARM TO THE PATIENT, BUT IT DID REQUIRE A NEW SETUP. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? PATIENT HAD VERSED INFUSING TO PROTECT AIRWAY. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) -DEVICE FAILED (E G. BROKE, COULDN'T GET IT TO WORK OR STOPPED
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10445932 ↗MalfunctionAug 24, 2020Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate
IT WAS REPORTED THAT AS SYR PSD ASV 20D SMBORE SS 0.2M CV TUBING WAS OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:10798696 BATCH NO: UNKNOWN. IT WAS REPORTED THAT TUBING OCCLUDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10444465 ↗MalfunctionAug 21, 2020Complete Blockage; Restricted Flow rate; Leak/Splash; Complete Blockage; Restricted Flow rate; Leak/Splash
IT WAS REPORTED THAT AS SYR PSD ASV 20D SMBORE SS 0.2M CV TUBING WAS OCCLUDED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:10798696 BATCH NO: UNKNOWN IT WAS REPORTED THAT THERE WAS A LEAKAGE WITH THE TUBING. I DON¿T HAVE MUCH INFO AT THIS POINT BUT BAPTIST LITTLE ROCK IS REPORTING LEAKING AND OCCLUSIONS WITH THE 10798696. I WILL FIND OUT MORE DETAILS TOMORROW.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10437827 ↗MalfunctionJan 14, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE 0.2 MICRON FILTER USED FOR A TOTAL PARENTERAL NUTRITION (TPN), INFUSION LEAKED ON A PREMATURE PATIENT IN THE NEONATAL INTENSIVE CARE UNIT (NICU). IT WAS FURTHER CONFIRMED DURING FOLLOW UP, THAT THERE WAS NO PATIENT HARM OR IMPACT AS A RESULT OF THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9589081 ↗MalfunctionOct 2, 2019Fluid/Blood Leak; Obstruction of Flow; Fluid/Blood Leak; Obstruction of Flow
RECEIVED A COPY OF THE CUSTOMER'S SUS VOLUNTARY EVENT REPORT FROM FDA WHICH STATES, ¿ADMIN SET TUBING LEAKING AT FILTER AND WILL NOT PRIME CORRECTLY." THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Information; No Patient Involvement
MAUDE report 9146821 ↗MalfunctionSep 23, 2019Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER LATER REPORTED THAT WHEN THE NURSES ATTEMPTED TO PRIME THE TUBING SETS, IT WAS FOUND THAT THEY LEAKED AROUND THE FILTER AND WOULD NOT PRIME. THIS HAPPENED TWO SEPARATE TIMES, ONE ON (B)(6) 2019 AND THE OTHER SET ON (B)(6) 2019, AS WELL AS, THERE HAVE BEEN SEVERAL REPORTED EVENTS OVER THE PAST TWO OR THREE MONTHS. UPON RECEIPT OF THE RETURNED PRODUCTS, IT WAS FOUND THAT IT WAS STATED ON A HAND-WRITTEN NOTE THAT ONE OF THE REPORTED TUBING SETS FILTER LEAKED AFTER BEING IN USE FOR 2 HOURS. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO PATIENTS FROM THE EVENTS.
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 9107772 ↗MalfunctionSep 23, 2019Fluid/Blood Leak; Fluid/Blood Leak
RECEIVED A COPY OF THE CUSTOMER'S SUS VOLUNTARY EVENT REPORT FROM FDA WHICH STATES, ¿IV TUBING LEAKING AT FILTER SITE, NO HARM TO PT." THE CUSTOMER LATER REPORTED THAT WHEN THE NURSES ATTEMPTED TO PRIME THE TUBING SETS, IT WAS FOUND THAT THEY LEAKED AROUND THE FILTER AND WOULD NOT PRIME. THIS HAPPENED TWO SEPARATE TIMES, ONE ON (B)(6) 2019 AND THE OTHER SET ON (B)(6) 2019, AS WELL AS, THERE HAVE BEEN SEVERAL REPORTED EVENTS OVER THE PAST TWO OR THREE MONTHS. UPON RECEIPT OF THE RETURNED PRODUCTS, IT WAS FOUND THAT IT WAS STATED ON A HAND-WRITTEN NOTE THAT ONE OF THE REPORTED TUBING SETS FILTER LEAKED AFTER BEING IN USE FOR 2 HOURS. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO PATIENTS FROM THE EVENTS.
Patient problems: No Consequences Or Impact To Patient; No Patient Involvement
MAUDE report 9107685 ↗MalfunctionNov 19, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FILTER CRACKED AND LEAKED DURING PATIENT USE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8084317 ↗MalfunctionNov 16, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FILTER CRACKED AND LEAKED DURING PATIENT USE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8080072 ↗MalfunctionNov 16, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FILTER CRACKED AND LEAKED DURING PATIENT USE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8080058 ↗MalfunctionNov 16, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FILTER CRACKED AND LEAKED DURING PATIENT USE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8079648 ↗MalfunctionNov 16, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FILTER CRACKED AND LEAKED DURING PATIENT USE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8079604 ↗MalfunctionNov 16, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FILTER CRACKED AND LEAKED DURING PATIENT USE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8079603 ↗MalfunctionNov 16, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FILTER CRACKED AND LEAKED WHILE ATTACHED TO THE UMBILICAL VENOUS CATHETER DURING PATIENT USE IN THE NICU ROOM 1. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8079503 ↗MalfunctionNov 16, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FILTER CRACKED AND LEAKED DURING PATIENT USE. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8079497 ↗MalfunctionNov 16, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FILTER CRACKED AND LEAKED, AND THE SET ALSO LEAKED AT THE PRESSURE SENSING DISC DURING PATIENT USE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8079496 ↗MalfunctionNov 16, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FILTER CRACKED AND LEAKED DURING PATIENT USE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8079186 ↗MalfunctionNov 16, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FILTER CRACKED AND LEAKED DURING PATIENT USE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8079141 ↗MalfunctionNov 16, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE PRESSURE SENSING DISC LEAKED DURING PATIENT USE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8078982 ↗MalfunctionNov 12, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE TUBING SET LEAKED AT THE FILTER SITE SHORTLY AFTER BEING PRIMED AND HUNG ON THE PATIENT. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8062457 ↗MalfunctionOct 30, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FILTER LEAKED DURING PATIENT USE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8022467 ↗MalfunctionOct 30, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE TUBING SET LEAKED AT THE POSTERIOR END OF THE FILTER WHILE INFUSING A TPN VIA THE PATIENT'S PERIPHERAL IV. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8020988 ↗MalfunctionOct 23, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FILTER CRACKED AND LEAKED DURING PATIENT USE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7997253 ↗MalfunctionOct 23, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE FILTER CRACKED AND LEAKED DURING PATIENT USE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7997245 ↗MalfunctionOct 23, 2018Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THEY ARE EXPERIENCING MULTIPLE EVENTS IN WHICH THE PRESSURE SENSING DISC LEAKS DURING PATIENT USE. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7997198 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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