Alaris 11088483Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10885403234668), received between Nov 16, 2018 and Sep 29, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935986 ↗
• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935982 ↗
• MalfunctionSep 29, 2026Break

  It was reported that the BD Alaris Extension Set had damaged tubing. The following information was provided by the initial reporter: We are still experiencing tubing that is ¿breaking.¿ Our clinical staff in CW has most recently reported the following: 4 Extension Set: UMID 1609 MFG# 11088483Additional Information Received from the Customer:Was the fault observed before priming, during priming or after priming the set? Most are after priming and standard use, some occur during primingPlease confirm the exact location of the reported fault within the set? At the Leur connection Did it fall apart at where the tubing connects? YesWhat was the impact to the patient? Loss of drug; risk of infectionCan you please provide an exact date of event in format dd-mmm-yyyy? Too many dates to provide. Risk reports were createdCan you please provide the Lot number associated with reported issue? I do not have specific Lot numbers as this has occurred over a several month period and the packaging has been thrown out as part of setting up the tubing.Can you please confirm all 4 Extension Set involve same patient or different patients? Different patients

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935980 ↗
• MalfunctionSep 29, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935974 ↗
• MalfunctionJul 27, 2026Obstruction of Flow

  sample investigation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50021584 ↗
• MalfunctionAug 21, 2024Break; Break

  IT WAS REPORTED THAT BD ALARIS EXTENSION SET COLLAR BROKE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: REPORTED ISSUE: PATIENT RETURNED FROM OR WITH A LEASH ATTACHED TO PIV. THE PLASTIC HUB AT THE END OF THE LEASH WHICH CONNECTS TO THE LEUR LOCK CLEAR LINK ON THE PIV WAS BROKEN. THE PLASTIC HUB BECAME DISLODGED AND THE INTERNAL PART WAS STUCK FIRMLY IN THE CLEAR LINK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20016590 ↗
• MalfunctionMay 14, 2024Break; Break

  NO ADDITIONAL INFO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19312960 ↗
• MalfunctionJul 17, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE WITH BD ALARIS¿ EXTENSION SET LEAKAGE OCCURRED WHEN CONNECTED TO MICROCLAVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: XXX HAS EXPERIENCED ISSUES WITH LEAKS WHEN CONNECTING YOUR PRODUCT WITH A MICROCLAVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17337885 ↗
• MalfunctionApr 3, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ALARIS¿ EXTENSION SETS LEAKED FROM THE CONNECTION SITES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE RECENTLY BEEN MADE AWARE THAT OUR SMALL BORE IV EXTENSION TUBING HAS BEEN LEAKING AT THE CONNECTION SITES CONSISTENTLY AMONG MULTIPLE SETS. THIS ISSUE WAS AS WELL REPORTED TO OUR CN ON NIGHT SHIFT BY THE MRI TECHNICIANS WHO NOTED THAT THIS ISSUE WAS NOTED BY OTHER NURSES FROM MULTIPLE UNITS IN THE HOSPITAL.. WE DO HAVE SOME SIMILAR TUBING WITH A DIFFERENT LOT NUMBER THAT HAS NOT GIVEN US ANY ISSUES SO I DO BELIEVE THAT THIS IS ISOLATED TO THIS PARTICULAR LOT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16665823 ↗
• MalfunctionApr 26, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE EXT SET¿¿DEHP FREE WAS DISCOLORED AT THE TUBING CONNECTION SITE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " OPENED ANOTHER ONE AND I COULD SEE THAT THERE WAS A DISCOLORATION AT THE SITE WHERE IT SHOULD HOOK ONTO THE TUBING. I FLUSHED IT AND WAS UNABLE TO DETERMINE IF IT WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11729711 ↗
• MalfunctionSep 29, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT EXT SET DEHP FREE HUB CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 11088483, BATCH NO: UNKNOWN. IT WAS REPORTED THAT TUBING CRACKED WHEN SYRINGE TWISTED ONTO TUBING TO FLUSH LASIX. (B)(4). WAS THE SYRINGE INVOLVED IN THE INCIDENT A BD SYRINGE? YES, BOTH SYRINGES INVOLVED, THE FLUSH AND LASIX, WERE BD SYRINGES. IF SO, CAN YOU PROVIDE THE PART NO. AND BATCH NO.? UNKNOWN. WAS THERE ANY ADVERSE EVENT(S) AS A RESULT OF THE REPORTED DEFECT? NONE REPORTED. IF YES, PLEASE PROVIDE DETAILS, IN ADDITION TO PATIENT IDENTIFIERS (INITIALS, SEX, DOB, DIAGNOSIS, ETC.) AND DATE. N/A.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10604063 ↗
• MalfunctionSep 29, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT EXT SET DEHP FREE HUB CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 11088483 BATCH NO: UNKNOWN. IT WAS REPORTED THAT HUB CRACKED ON MED LINE. CUSTOMER RESPONSE 16-SEP-2020: (B)(6) ((B)(4)): WAS THERE ANY ADVERSE EVENT(S) AS A RESULT OF THE REPORTED DEFECT? NONE REPORTED. O IF YES, PLEASE PROVIDE DETAILS, IN ADDITION TO PATIENT IDENTIFIERS (INITIALS, SEX, DOB, DIAGNOSIS, ETC.) AND DATE. N/A.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10604061 ↗
• MalfunctionNov 14, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED SEVERAL DIFFERENT LEAKS OCCURRED AT THE NEEDLELESS CONNECTORS DURING A PATIENT'S INFUSION WITH SEVERAL MEDICATIONS. THERE WAS NO PATIENT HARM. THREE NEEDLELESS CONNECTORS WERE ATTACHED TO MICROBORE EXTENSION TUBINGS. TWO OF THESE NEEDLELESS CONNECTORS HAD A PIECE OF TAPE WITH "LEAK" NOTED. THE EXTENSIONS WERE ATTACHED TO THREE ADDITIONAL NEEDLELESS CONNECTORS ON THE ENDS OF A TRIFUSE EXTENSION SET. THE LINES WERE LABELED "FENTANYL," "VERSED," AND "INTERMITTENT." THE FENTANYL AND VERSED LINES HAD A PIECE OF TAPE WITH "LEAK" NOTED NEXT TO THE NEEDLELESS CONNECTOR. THE MALE END OF THE TRIFUSE HAD A LABEL INDICATING THAT IT HAD BEEN ATTACHED TO A T-CONNECTOR EXTENSION SET LEADING TO THE PATIENT'S IV ACCESS DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9322251 ↗
• MalfunctionNov 14, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED SEVERAL DIFFERENT LEAKS OCCURRED AT THE NEEDLELESS CONNECTORS DURING A PATIENT'S INFUSION WITH SEVERAL MEDICATIONS. THERE WAS NO PATIENT HARM. THREE NEEDLELESS CONNECTORS WERE ATTACHED TO MICROBORE EXTENSION TUBINGS. TWO OF THESE NEEDLELESS CONNECTORS HAD A PIECE OF TAPE WITH "LEAK" NOTED. THE EXTENSIONS WERE ATTACHED TO THREE ADDITIONAL NEEDLELESS CONNECTORS ON THE ENDS OF A TRIFUSE EXTENSION SET. THE LINES WERE LABELED "FENTANYL," "VERSED," AND "INTERMITTENT." THE FENTANYL AND VERSED LINES HAD A PIECE OF TAPE WITH "LEAK" NOTED NEXT TO THE NEEDLELESS CONNECTOR. THE MALE END OF THE TRIFUSE HAD A LABEL INDICATING THAT IT HAD BEEN ATTACHED TO A T-CONNECTOR EXTENSION SET LEADING TO THE PATIENT'S IV ACCESS DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9322145 ↗
• MalfunctionNov 6, 2019Leak/Splash

  IT WAS REPORTED THAT THERE WAS LEAKING OF MEDICATION AT THE NEEDLELESS CONNECTOR DURING A SYRINGE PUMP INFUSION. THE SYRINGE LABEL INDICATED THAT DEXAMETHASONE IVP 8 MG IN 20 ML WAS EXPECTED TO INFUSE OVER 30 MINUTES. ALTHOUGH REQUESTED, NO OTHER PATIENT OR EVENT DETAILS WERE AVAILABLE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9284607 ↗
• MalfunctionNov 6, 2019Leak/Splash

  IT WAS REPORTED THAT A LEAK AT THE NEEDLELESS CONNECTOR OCCURRED DURING A 10 ML NORMAL SALINE FLUSH. THE RN FURTHER STATED DURING FOLLOW-UP THAT THERE WAS NO OTHER EVENT DETAILS OR PATIENT DEMOGRAPHICS AVAILABLE, OTHER THAN WHAT WAS SENT WITH THE PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9284537 ↗
• MalfunctionNov 6, 2019Leak/Splash

  IT WAS REPORTED THAT A LEAK AT THE NEEDLELESS CONNECTOR OCCURRED DURING A 10 ML NORMAL SALINE FLUSH. THE RN FURTHER STATED DURING FOLLOW-UP THAT THERE WAS NO OTHER EVENT DETAILS OR PATIENT DEMOGRAPHICS AVAILABLE, OTHER THAN WHAT WAS SENT WITH THE PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9284535 ↗
• MalfunctionJul 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE INFANTS MOTHER NOTICED THAT THE PATIENTS BLANKETS WERE WET DURING A 6.9ML FLUSH INFUSING FROM A 10ML SYRINGE AFTER A HYDROCORTISONE 3ML DOSE WAS ADMINISTERED VIA THE PATIENT'S BROVIAC CENTRAL LINE LOCATED IN THE PATIENT'S LEFT FEMORAL ARTERY.

  Patient problems: No Information

  MAUDE report 8786595 ↗
• MalfunctionApr 23, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TUBING DISCONNECTED AND LEAKED AT THE NEEDLELESS CONNECTOR DURING A FENTANYL INFUSION. THERE WAS NO PATIENT HARM AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8540551 ↗
• MalfunctionNov 16, 2018Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE FILTER CRACKED AND LEAKED DURING PATIENT USE IN NICU ROOM 2. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8079516 ↗