Pyxis TRANSFUSIONRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403421532), received between Nov 5, 2018 and Jun 15, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD¿ INSULIN SYRINGE WAS "DARK" UP TO THE 5 UNIT MARK. THIS WAS NOTICED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER LEFT VOICEMAIL STATING THAT THE SYRINGES ARE DARK. I RETURNED CONSUMER'S CALL, SHE STATED THAT A SECTION OF THE SYRINGES ARE DARK UP TO THE 5 UNIT MARK. CONSUMER SAID SHE NOTICED IT ABOUT ONE WEEK AGO, ALOS SAID SHE DOES NOT RE-USE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10156239 ↗
• MalfunctionApr 3, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE CONSUMER NOTICED A FOREIGN, CLEAR MOISTURE IN THE BD¿ INSULIN SYRINGE BEFORE USE, AND UPON DRAWING UP INSULIN, THE FOREIGN LIQUID CONTAMINATED THE VIAL AND MADE THE INSULIN "CLOUDY". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE BEEN USING BD INSULIN SYRINGES FOR OVER 5 YEARS TO GIVE OUR YOUNGEST DAUGHTER, AGE (B)(6) NOW, INSULIN INJECTIONS. FROM TIME TO TIME WE HAVE OBSERVED MOISTURE IN UNUSED SYRINGES PRIOR TO USE. WHEN OBSERVED, WE HAVE BEEN DISCARDING THE SYRINGES. HOWEVER, THE PROBLEM HAS RECENTLY GOTTEN WORSE. MOREOVER, WE ARE APPARENTLY NOT ABLE TO DETECT THE MOISTURE EVERY TIME BECAUSE WE HAVE ALSO OBSERVED VIALS OF INSULIN TURNING CLOUDY AFTER JUST A FEW DRAWS OF INSULIN. THIS HAS LED US TO DISCARD VIALS OF INSULIN LONG BEFORE WE WOULD OTHERWISE NORMALLY DISCARD THEM. WE BELIEVE THE CLOUDINESS IS THE RESULT OF SOME OF THE UNDETECTED MOISTURE BEING PUSHED BACK INTO THE VIALS WHEN ATTEMPTING TO ELIMINATE ANY SMALL AIR BUBBLES FROM THE DRAWN INSULIN. WHEN I SPOKE WITH CONSUMER ON CALL BACK, HE STATED HE HAD ISSUE WITH TWO BOXES, SAME LOT: 8128858. STATED NOTICED "MOISTURE"=CLEAR LIQUID IN SYRINGES BEFORE USE. STATED WHEN HE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8479672 ↗
• MalfunctionFeb 14, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A 6MM BD INSULIN SYRINGE WAS FOUND WITH A SLANTED STOPPER BEFORE USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8340462 ↗
• MalfunctionJan 10, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SHIELDS WERE DIFFICULT TO REMOVE FROM THE BD¿ INSULIN SYRINGES, AND THE NEEDLE HUB SEPARATED FROM ONE SYRINGE INTO THE SHIELD.

  Patient problems: No Information

  MAUDE report 8234890 ↗
• MalfunctionNov 5, 2018Disconnection; Material Separation; Component Missing

  IT WAS REPORTED THAT A PACKAGE OF BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES HAD DISCONNECTED NEEDLE SHIELDS, A MISSING PLUNGER CAP, AND NEEDLE AND SYRINGE SEPARATION. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8038925 ↗