CADD 21-7036-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10610586020186), received between Feb 17, 2017 and Dec 5, 2020 — classified as 12 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (26 reports).

1 other recall cover devices cleared under the same FDA submission (K933390); they may or may not involve this specific model.

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 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT CADD ADMINISTRATION SETS - NON-FLOW STOP LEAKED. THE TUBE WAS CHANGED TO RESOLVE THE ISSUE. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10950898 ↗
• MalfunctionOct 21, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT CADD ADMINISTRATION SETS - NON FLOW STOP LEAKED FROM THE FILTER. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10714394 ↗
• MalfunctionOct 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TUBING WAS LEAKING AND IT WAS NOTED THAT THERE WERE 3 DOSES OF IV PIP/TAZO WAS WASTED. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: No Information

  MAUDE report 10684261 ↗
• MalfunctionOct 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TUBING WAS LEAKING AND THE CADD TUBING WAS LEAKING FROM THE FILTER. THERE WAS NO REPORTED HARM TO THE PATIENT. THERE WERE NO REPORTED ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10683830 ↗
• MalfunctionSep 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS IN USE AND THE DEVICE LEAKED NEAR THE AIR FILTER. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10603234 ↗
• MalfunctionSep 22, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A NURSE PRIMED AN EPIDURAL TUBING MANUALLY WITH AN EPIDURAL BAG, THEN NOTICED THAT FLUID WAS LEAKING FROM THE TUBING. A CUT/BREAK WAS FOUND ON THE PRODUCT SO ANOTHER EPIDURAL TUBING AND EPIDURAL BAG WAS OPENED, PRIMED AND USED WITHOUT A PROBLEM. THE AFFECTED PRODUCT WAS DISCARDED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. THERE WAS ONLY A SHORT DELAY IN THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10567976 ↗
• MalfunctionJun 15, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SETS - NON FLOW STOP WAS FILLED WITH AIR AFTER THE AIR FILTER AND THAT THE MEDICATION WAS LEAKING. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Information

  MAUDE report 10152740 ↗
• MalfunctionJun 10, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT TUBING WAS LEAKING WHERE CADD TUBING FUSES INTO THE LUER LOCK, CONNECTING TO THE PATIENT. NO ADVERSE EFFECTS OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10137672 ↗
• MalfunctionJun 9, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED THAT DURING USING OF THIS SMITHS MEDICAL CADD ADMINISTRATION SETS, LEAKING WAS NOTICED FROM THE SET AIR FILTER AT THE TOP LEFT CORNER ON THE GREEN BACKING SIDE. IT WAS REPORTED THAT THE PATIENT WAS CONNECTED TO THE INFUSION AND IT WAS STARTED, AND IT WAS NOTED THAT THERE WAS A SMALL WET SPOT ON THE CLIENT'S BEDDING. ACCORDING TO THE REPORT, UPON INSPECTION OF THE TUBING IT WAS NOTED THAT THE AIR FILTER WAS LEAKING AT THE TOP LEFT CORNER ON THE GREEN BACKING SIDE. NO REPORTED ADVERSE EFFECTS OR PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10134804 ↗
• MalfunctionJun 5, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A HOME CARE NURSE FOUND A TUB LEAKING ABOVE THE FILTER OF A SMITHS MEDICAL ADMINISTRATION SET. THERE WAS NO DIRECT HARM TO THE PATIENT. TUBING RETAINED IN PATIENT'S HOME AT THIS TIME. IF NEEDED FOR FURTHER INVESTIGATION, HPT CAN MAKE ARRANGEMENTS WITH PATIENT TO RETRIEVE TUBING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10126045 ↗
• MalfunctionJun 2, 2020Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET TUBING WAS LEAKING NEAR WHERE IT CONNECTS TO DISTAL END OF CASSETTE. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10108663 ↗
• MalfunctionApr 24, 2020Burst Container or Vessel; Burst Container or Vessel

  INFORMATION WAS RECEIVED INDICATING THAT THE IV BAG RUPTURED WHEN SPIKED WITH THE CADD ADMINISTRATION SETS - NON FLOW STOP. THE ISSUE WAS DISCOVERED BEFORE THE DEVICE WAS ATTACHED TO THE PATIENT. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9998511 ↗
• MalfunctionMar 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT THE CADD ADMINISTRATION SET LEAKED AT THE FILTER DURING PRIMING. THERE WAS NO REPORTED INJURY OR ADVERSE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9895097 ↗
• MalfunctionJan 27, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET LEAKED A SIGNIFICANT AMOUNT OF BLOOD AND THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE WAS BROKEN IN TWO, CRACKING THE AIR FILTER. THE REPORTER INDICATED THAT PER THE CLIENT, THE CAUSE OF THE DAMAGE IN THIS EVENT WAS UNKNOWN. NO FURTHER ADVERSE EFFECTS WERE REPORTED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9633799 ↗
• MalfunctionJan 14, 2020Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET WAS CRACKED BY THE CASSETTE AND CAUSING LEAKING OF IV MEDICATION. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9587635 ↗
• MalfunctionJan 6, 2020Connection Problem; Protective Measures Problem; Connection Problem; Protective Measures Problem

  INFORMATION RECEIVED A SMITHS MEDIAL CADD ADMINISTRATION CASSETTE WOULD NOT ATTACH TO PUMP AND ONLY DID AFTER CHANGING TUBING. THIS ALARM OCCURED MULTIPLE TIMES, INTERRUPTING THERAPY. NO PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9555385 ↗
• MalfunctionAug 8, 2019Device Alarm System; Device Alarm System

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET SPIKE 0.2 FLTR COILED TUBE BLUE STRIPE PUMP WAS ALARMING CASSETTE NOT ATTACHED. RESOURCE LINE DIRECTED ON THE PHONE HOW TO RESOLVE ISSUE AND STEPS WERE IMPLEMENTED, INCLUDING CHANGING BATTERIES. CADD PUMP WAS EXCHANGED AND THE SAME CASSETTE WAS REATTACHED WITH NO RESOLVING ISSUE. CHANGED TO A NEW CASSETTE ON THE NEW PUMP AND ISSUE RESOLVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8874757 ↗
• MalfunctionAug 8, 2019Infusion or Flow Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE MEDICATION BAG WAS FULL AND ALTHOUGH THE PUMP ACKNOWLEDGED THAT THE FLUID WAS RUNNING, NO FLUID WAS COMING OUT OF THE SMITHS MEDICAL CADD ADMINISTRATION SET. THE REPORTER INDICATED THAT THE STAFF TRIED TO BOLUS THE FLUID WHEN NOT CONNECTED TO THE PATIENT, BUT NO FLUID CAME OUT OF THE TUBING. SUBSEQUENTLY, ANOTHER SET OF TUBING WAS PRIMED AND USED WITH NO ISSUES IDENTIFIED. THE IMPACT OF THE REPORTED ISSUE WAS THAT THE PATIENT ENDED UP NOT RECEIVING HER PAIN MEDICATION AND WAS IN PAIN, UNNECESSARILY. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 8874011 ↗
• MalfunctionJun 20, 2019Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION WAS RECEIVED THAT THIS SMITHS MEDICAL CADD ADMINISTRATION SETS EXPERIENCED LEAK TUBING. IT WAS REPORTED THAT THE CLINICIAN NOTED THE TUBING WAS LEAKING NEAR THE AIR FILTER. SUBSEQUENTLY, THE TUBING WAS CHANGED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8717143 ↗
• MalfunctionJun 7, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD BLUE-STRIPED IV ADMINISTRATION SET WAS LEAKING AT THE AIR ELIMINATING FILTER. IT WAS REPORTED THAT PRIMING THE TUBING WAS NOT POSSIBLE DUE TO THE LEAK. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8679328 ↗
• MalfunctionFeb 21, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT THE CADD EXTENSION SET TUBING WAS LEAKING AT THE DISTAL END OF CASSETTE AS SOON AS TUBING WAS ATTACHED TO PATIENT. NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Patient Involvement

  MAUDE report 8360704 ↗
• MalfunctionNov 28, 2018Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED INDICATING THAT THIS INFUSION ADMINISTRATION SET WOULD NOT PRIME AND THE LINE WAS FULL OF AIR. THE MEDICATION HAD TO BE HUNG AND DELIVERED VIA GRAVITY AS THE PATIENT HAD NO EXTRA TUBING. THIS INCREASED THE MEDICATION ADMINISTRATION TIME ALMOST AN HOUR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8112485 ↗
• MalfunctionSep 17, 2018Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A CADD® CADD® ADMINISTRATION SET CAUSED A CADD PUMP TO ALARM "UPSTREAM OCCLUSION". NO VISUALIZED DEFECT NOTED. NO ADVERSE EVENTS TO THE PATIENT. THE PRODUCT CONCERN WAS NOTED PRIOR TO USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7883672 ↗
• MalfunctionSep 14, 2018Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT THE ADMINISTRATION SET FOR A PUMP TUBING WAS LEAKING AT THE AIR FILTER DURING USE. LINE APPEARS TO BE CRACKED. NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7878449 ↗
• MalfunctionMay 21, 2018Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT USING THIS ADMINISTRATION SET HAD A PERIPHERALLY INSERTED CENTRAL CATHETER THAT WAS BEING "SLUGGISH" OVER THE COURSE OF TWO DAYS. IT WAS NOTED THAT 200 ML OF 600 ML OF FLUIDS WERE LEFT IN THEIR IV BAG WHEN THE PUMP READ THAT ONLY 10.5 ML WERE LEFT IN THE BAG. THE PUMP PROGRAMMING WAS CHECKED AND CONFIRMED TO BE SET CORRECTLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7531227 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K933390. One submission often covers many models, so check the product and lot details in each record.

• Z-2759-2017 · Dec 9, 2016 · Terminated
  Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.