Alaris 72213NRecalls & reported problems
BD Switzerland Sàrl · Secondary Set, 79 cm (31 in) · Class 2
Quick summary
This BD Alaris secondary infusion set is tubing used to give a second IV medicine through a primary line. Many of the 82 reports describe tubing separating or leaking, fluid flowing back into the wrong bag, and flow blockages. The reports include no injuries and no deaths. No recalls name this device.
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
- 82
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 07613203010078), received between Mar 28, 2019 and May 21, 2025 — classified as 82 malfunctions.
The most frequently reported specific device problem is “Material Separation” (23 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.
Reports received per month
Most reported problems
Device problems
- Material Separation23
- Leak/Splash19
- Backflow7
- Complete Blockage5
- Fluid/Blood Leak4
- Improper Flow or Infusion4
- Break3
- Device Contamination with Chemical or Other Material3
Patient problems
- No Clinical Signs, Symptoms or Conditions39
- No Consequences Or Impact To Patient23
- No Patient Involvement10
- No Information8
- Insufficient Information3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2025Material Discolored; Material Discolored
IT WAS REPORTED THAT BD ALARIS SECONDARY SET DISCOLORATION. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY CUSTOMER THAT DISCOLORED TUBING
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22060875 ↗MalfunctionMay 2, 2025Material Separation; Material Separation
IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS DISCONNECTING. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. IT WAS REPORTED BY CUSTOMER THAT SECONDARY INFUSION SET DEVICE MALFUNCTION. THEY HAVE THE TUBING BUT NO LONGER HAVE THE PACKAGING. THE NURSE WAS JUST ABOUT TO SPIKE THE BAG AND THE TUBING DISCONNECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21951291 ↗MalfunctionDec 4, 2024Defective Device; Defective Device
IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT TUBING DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20844281 ↗MalfunctionNov 1, 2024Defective Component; Defective Component
IT WAS REPORTED THAT BD ALARIS SECONDARY SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING. I AM TRYING TO GET A HOLD OF A PICTURE THAT WAS TAKEN BUT THE NURSE WHO TOOK THE PICTURE IS OFF TODAY. BASICALLY, AN IRON PRODUCT WAS HANGING ON A SECONDARY TUBING SET AND SALINE IN THE PRIMARY LINE. THE PUMP CORRECTLY PULLED THE IRON PRODUCT BUT SOME OF THE PRODUCT BACK PRIMED INTO THE PRIMARY SALINE BAG. WHEN THE RN ENTERED THE ROOM THERE WAS VISIBLE IRON IN THE BOTTOM OF THE PRIMARY SALINE BAG. I AM UNSURE IF IT IS A PRIMARY TUBING ISSUE OR A SECONDARY TUBING ISSUE. HOPEFULLY THAT HELPS!
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20592112 ↗MalfunctionOct 14, 2024Backflow; Backflow
IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS MALFUNCTIONING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IVF FROM PRIMARY BAG BACK-FLOWED INTO THE SECONDARY ANTIBIOTIC BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20447304 ↗MalfunctionOct 14, 2024Backflow; Backflow
IT WAS REPORTED THAT BD ALARIS SECONDARY SET BACK FLOWED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: IVF FROM PRIMARY BAG BACK-FLOWED INTO THE SECONDARY ANTIBIOTIC BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20444826 ↗MalfunctionAug 20, 2024Infusion or Flow Problem; Infusion or Flow Problem
IT WAS REPORTED THAT BD ALARIS SECONDARY SET HAD FLOW ISSUES THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. IV SET UP VIA IV PUMP WITH PRIMARY TUBING AND SECONDARY TO ADMINISTERED IVPB. THIS SET UP WOULD NOT PULL FROM SECONDARY TUBING. PUMP WAS LOW AND BAGS WERE HANGING AT APPROPRIATE HEIGHTS. RN CHANGED SECONDARY TUBING WITH NO IMPROVEMENT. RN THEN CHANGED BOTH PRIMARY AND SECONDARY TUBING AND FLUID INFUSED WITHOUT ANY PROBLEMS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20004556 ↗MalfunctionJul 29, 2024Free or Unrestricted Flow; Air/Gas in Device; Free or Unrestricted Flow; Air/Gas in Device
NO ADDITIONAL INFO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19851414 ↗MalfunctionJun 19, 2024Leak/Splash; Leak/Splash
NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19570392 ↗MalfunctionJul 6, 2023Component Missing; Component Missing
IT WAS REPORTED THAT PRIOR TO USE WITH 2 BD ALARIS¿ SECONDARY SET THE DEVICE WAS DISCOVERED TO HAVE A PIECE MISSING WHILE IN THE PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT BD SECONDARY SET FOUND BROKEN IN PACKAGE. WHAT COMPONENT OF THE TUBING SET WAS DAMAGED/BROKEN/MISSING? THE CONNECTING PIECE IS MISSING. INCOMPLETE MANUFACTURING?
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17276177 ↗MalfunctionMay 10, 2023Break; Break
IT WAS REPORTED WHILE USING BD SECONDARY ADMINISTRATION SET, ROLLER CLAMP(S) SPIN MALE THE TUBING RUPTURED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REFERENCE NUMBER 72213N HAD A 5MM RUPTURE IN THE LINE BELOW THE CHAMBER.
Patient problems: Insufficient Information
MAUDE report 16908521 ↗MalfunctionMay 1, 2023Leak/Splash; Material Separation; Leak/Splash; Material Separation
IT WAS REPORTED THAT THE BD ALARIS SECONDARY SET EXPERIENCED COMPONENT SEPARATION AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I¿M HOPING YOU CAN ASSIST WITH A REPORT I RECEIVED REGARDING A SECONDARY SET THAT DISCONNECTED. FROM WHAT I LEARNED THE SET DISCONNECTED NEAR THE SPIKE AREA CAUSING SOLUTION TO LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16841903 ↗MalfunctionApr 21, 2023Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT THE BD ULTRA-FINE¿ MICRO PEN WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING CLOGGED NEEDLE DURING INJECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16790658 ↗MalfunctionApr 18, 2023Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT THE BD ULTRA-FINE¿ MICRO PEN WAS UNABLE TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, STATED THAT THERE IS NO INSULIN FLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16765517 ↗MalfunctionMar 13, 2023Contamination; Contamination
IT WAS REPORTED WHILE USING BD ALARIS SECONDARY SET PRODUCT WAS DISCOLORED WITH FOREIGN MATTER. THIS OCCURRED 3 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED ISSUE: SHOWING A YELLOWISH TINT VERSUS CLEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16529863 ↗MalfunctionMar 13, 2023Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT 3 BD ALARIS¿ SECONDARY SETS PRIMARY PACKAGING UNITS WERE FOUND DISCOLORED TO A YELLOWISH TINT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REPORTED ISSUE: SHOWING A YELLOWISH TINT VERSUS CLEAR."
Patient problems: Insufficient Information
MAUDE report 16527364 ↗MalfunctionMar 12, 2023Complete Blockage; Infusion or Flow Problem; Complete Blockage; Infusion or Flow Problem
IT WAS REPORTED THAT THE BD ALARIS SECONDARY SET EXPERIENCED TUBING KINKED AND FLOW ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD AN EVENT LAST WEEKEND IN WHICH A KINK IN THE TUBING DELAYED ADMINISTRATION OF ALTEPLASE FOR A PE. I WOULD LIKE TO LOG THAT INFO IN THE REFERRAL. ALSO, WOULD IT BE POSSIBLE TO REPORT THIS EVENT TO THE MANUFACTURER? WE HAD A SPATE OF SIMILAR EVENTS INVOLVING SECONDARY IV TUBING IN FEBRUARY OF 2022, AND I WOULD BE CURIOUS TO KNOW IF IT WAS THE SAME PRODUCT INVOLVED. I BELIEVE YOU REPORTED THOSE TO THE MANUFACTURER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16527222 ↗MalfunctionDec 8, 2022Defective Device; Defective Device
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ MICRO PEN NEEDLES EXPERIENCED THE INNER SHIELD BEING UNABLE TO ATTACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WIFE OF CONSUMER REPORTED SOMETIMES, WHEN ATTACHING TO PEN, CAN FEEL THE NON PATIENT END DOES NOT SCREW ONTO THE PEN STRAIGHT. SHE REMOVES AND ADJUSTS TO PLACE THE NEEDLE BACK ON PEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15939063 ↗MalfunctionNov 17, 2022Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT THE BD SEC SET 20DP 30IN W/HANGER LL EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN RN WENT TO SEE WHAT WAS TAKING SO LONG FOR THE SECONDARY INFUSION TO COMPLETE RN NOTICED THE PRIMARY WAS ABOUT DRY FROM INFUSING AND THERE WAS STILL DRUG IN THE SECONDARY BAG. CQI DATA SHOWS CORRECT PROGRAMMING AND RN CONFIRMED PHYSICAL SETUP WAS CORRECT. UNCLEAR WHY SECONDARY BAG DID NOT EMPTY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15820013 ↗MalfunctionNov 17, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED THAT 200 BD SEC SET 20DP 30IN W/HANGER LL WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSING IS STATING THAT THE SECONDARY SETS ARE CAUSING ISSUES WITH MED INFUSIONS. THE FILTER ISN¿T ALLOWING FOR PROPER INFUSION OF A SECONDARY WHEN ADMINISTERING WITH A GLASS BOTTLE (A FEW MEDS COME IN BOTTLES).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15819901 ↗MalfunctionNov 17, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED WHILE USING BD SEC SET 20DP 30IN W/HANGER LL THERE WAS A CLOG. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NURSING IS STATING THAT THE SECONDARY SETS ARE CAUSING ISSUES WITH MED INFUSIONS. THE FILTER ISN¿T ALLOWING FOR PROPER INFUSION OF A SECONDARY WHEN ADMINISTERING WITH A GLASS BOTTLE (A FEW MEDS COME IN BOTTLES)."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15813221 ↗MalfunctionNov 15, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT THE BD ULTRA-FINE¿ MICRO PEN NEEDLE WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING NEEDLE WOULD NOT ALLOW INSULIN THROUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15802651 ↗MalfunctionNov 14, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE BD SEC SET 20DP 30IN W/HANGER LL LEAKING AT THE JUNCTION END. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORT OF LEAKING AT THE JUNCTION END.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15795022 ↗MalfunctionNov 14, 2022Break; Break
IT WAS REPORTED THAT THE BD SEC SET 20DP 30IN W/HANGER LL BROKE OFF THE CONNECTION PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MALE TIP BROKE OFF IN FEMALE CONNECTION PORT OF LONG TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15794955 ↗MalfunctionOct 31, 2022Complete Blockage; Complete Blockage
IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ MICRO PEN NEEDLES 32G X 6MM (100 COUNT) THE PEN NEEDLES COULDN'T PRIME. THIS OCCURRED 5 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 5 PEN NEEDLES CLOG DURING THE FLOW CHECK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15705194 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.