BD SmartSite CM42500E-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10885403473746), received between Apr 17, 2023 and Jan 17, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Backflow” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2024Backflow; Backflow

  IT WAS REPORTED THAT BD GRAVITY SET VALVE MALFUNCTIONED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: A PROVIDER ATTACHED A PHENYLEPHRINE SYRINGE TO THE THREE WAY STOP COCK OF THE BD GRAVITY IV SET. ADMINISTERED 50MCG PHENYLEPHRINE. THEN ATTACHED A 10CC SYRINGE TO THE DISTAL SIDE PORT AND WITHDREW A FLUSH AND SUBSEQUENTLY PUSHED IT. NOT LONG AFTER THAT, THE PATIENT EXPERIENCED SIGNIFICANT AND CONCERNING HYPERTENSION. WITH INVESTIGATION, THE PHENYLEPHRINE SYRINGE WAS FOUND TO BE EMPTY ATTACHED TO THE THREE WAY STOP COCK. IN THE END, THE BACK CHECK VALVE FAILED, AND THE PHENYLEPHRINE SYRINGE WAS DRAWN UP INTO THE FLUSH SYRINGE AND ROUGHLY 1000MCG WAS PUSHED AS A BOLUS UNKNOWINGLY. OF NOTE, IF THE ROLLER BALL WAS WIDE OPEN, THE FLUSH SYRINGE DID NOT EMPTY THE STOP COCK SYRINGE. IT FOLLOWED THE PATH OF LEAST RESISTANCE AND PULLED FROM THE IV FLUID BAG. IF WE CLOSED THE ROLLER BALL AT ALL, THE STOP COCK SYRINGE WAS ASPIRATED INTO THE FLUSH SYRINGE.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 18531925 ↗
• MalfunctionJan 17, 2024Backflow; Backflow

  IT WAS REPORTED THAT BD GRAVITY SET VALVE MALFUNCTIONED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: I WANTED TO BRING TO YOUR ATTENTION AN ISSUE WE HAD THIS MORNING AT UNION. A PROVIDER ATTACHED A PHENYLEPHRINE SYRINGE TO THE THREE WAY STOP COCK OF THE BD GRAVITY IV SET. ADMINISTERED 50MCG PHENYLEPHRINE. THEN ATTACHED A 10CC SYRINGE TO THE DISTAL SIDE PORT AND WITHDREW A FLUSH AND SUBSEQUENTLY PUSHED IT. NOT LONG AFTER THAT, THE PATIENT EXPERIENCED SIGNIFICANT AND CONCERNING HYPERTENSION. WITH INVESTIGATION, THE PHENYLEPHRINE SYRINGE WAS FOUND TO BE EMPTY ATTACHED TO THE THREE WAY STOP COCK. WE GRABBED A FEW OTHER PACKAGES OF IV TUBING AND WERE ABLE TO RECREATE WHAT HAPPENED. I AM ATTACHING A VIDEO HERE. IN THE END, THE BACK CHECK VALVE FAILED AND THE PHENYLEPHRINE SYRINGE WAS DRAWN UP INTO THE FLUSH SYRINGE AND ROUGHLY 1000MCG WAS PUSHED AS A BOLUS UNKNOWINGLY.

  Patient problems: Insufficient Information

  MAUDE report 18531810 ↗
• MalfunctionMay 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INFO CAPTURED FROM PR#7548204 ENTRY DESCRIPTION. IT WAS REPORTED BY CUSTOMER THAT OVER THE WEEKEND, ONE OF OUR NURSES OPENED A GRAVITY SET AND THE SPIKE FILTER COMPONENT WAS NOT ATTACHED TO THE TUBING. NO PATIENT HARM AND DID NOT DELAY THE PROCEDURE (EXCEPT TO GO GET SECOND SET). VERBATIM: HELLO, OVER THE WEEKEND, ONE OF OUR NURSES OPENED A GRAVITY SET AND THE SPIKE FILTER COMPONENT WAS NOT ATTACHED TO THE TUBING. NO PATIENT HARM. DID NOT DELAY PROCEDURE (EXCEPT TO GO GET SECOND SET). REF # CM42500E-07. LOT #2209417. EXP 10-25-2023. ADDITIONAL INFO RECEIVED ON 05-APR-2023. ARE YOU ABLE TO ADVISE OCCURRENCE DATE? 03-29 & 30-2023. ANY DAMAGED OBSERVED ON GRAVITY SETS OR PACKAGING? NO . ARE YOU ABLE TO RETURN FAULTY GRAVITY SETS BACK TO BD FOR INVESTIGATION? IF NO, CAN A PHOTO BE PROVIDED? YES. CLARIFICATION OF EVENT DATE RECEIVED ON 08-APR-2023. ADDITIONAL RECORD PR#(B)(4) OPENED ON 13-APR-2023 TO CAPTURE INCIDENT OCCURRED ON (B)(6) 2023. PR#(B)(4) ALREADY OPENED ON 29-MAR-2023 TO CAPTURED INCIDENT OCCURRED ON (B)(4) 2023. PR#(B)(4

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16845944 ↗
• MalfunctionApr 27, 2023Component Missing; Component Missing

  IT WAS REPORTED WHILE USING BD GRAVITY IV SETS THE ROLLER CLAMP WAS MISSING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MISSING ROLLER CLAMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16826193 ↗
• MalfunctionApr 18, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE BD ALARIS SMARTSITE GRAVITY SET EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HELLO, WE JUST HAD A SECOND TUBING SET WITH THE SAME ISSUE. IT WAS REPORTED BY CUSTOMER THAT OVER THE WEEKEND, ONE OF OUR NURSES OPENED A GRAVITY SET AND THE SPIKE FILTER COMPONENT WAS NOT ATTACHED TO THE TUBING. NO PATIENT HARM AND DID NOT DELAY THE PROCEDURE (EXCEPT TO GO GET SECOND SET).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16764131 ↗
• MalfunctionApr 17, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ GRAVITY SET SEPARATED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OVER THE WEEKEND, ONE OF OUR NURSES OPENED A GRAVITY SET AND THE SPIKE FILTER COMPONENT WAS NOT ATTACHED TO THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16753320 ↗