CADD 21-2188-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10610586035029), received between Oct 15, 2018 and Oct 21, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LOCK HAS FALLEN OUT OR/SNAPPED OFF OF THE PUMP. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15649243 ↗
• MalfunctionMay 7, 2022Crack; Crack

  (2 OF 2) IT WAS REPORTED THAT THE PLASTIC ON ALL 10 OF THE CUSTOMERS LOCKBOXES APPEAR CRACKED AND AS IF 'SHATTERED'. THEY ARE CONCERNED ABOUT THE INFECTION CONTROL RISK OF THEM NOT BEING FULLY INTACT AND THEY LOOK AWFUL TO BOTH THE CUSTOMER AND PATIENTS. THE SHATTERED EDGES CAN ALSO BE SHARP AND UNSAFE FOR THE USER. ONGOING ISSUE OVER LAST 18 MONTHS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14314016 ↗
• MalfunctionOct 20, 2019Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED INDICATING THAT IMMEDIATELY ON USE, THE SMITHS MEDICAL CADD ACCESSORY KEPT ON BREAKING AND ULTIMATELY FALLING OUT. THE REPORTER INDICATED THAT REPLACEMENT OF THE LOCKS DID NOT SOLVE THE ISSUE, AND THAT THE LOCK BOXES WERE FAULTY. THE REPORTER ALSO INDICATED THAT THE PATIENT HAD REMOVED THE MEDICATION AND STAFF CAUGHT THEM. NO PATIENT CONSEQUENCES WERE REPORTED, AND NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9212576 ↗
• MalfunctionMay 1, 2019Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED INDICATING THAT IMMEDIATELY ON USE, THE SMITHS MEDICAL CADD ACCESSORY KEPT ON BREAKING AND ULTIMATELY FALLING OUT. THE REPORTER INDICATED THAT REPLACEMENT OF THE LOCKS DID NOT SOLVE THE ISSUE, AND THAT THE LOCK BOXES WERE FAULTY. THE REPORTER ALSO INDICATED THAT THE PATIENT HAD REMOVED THE MEDICATION AND STAFF CAUGHT THEM. NO PATIENT CONSEQUENCES WERE REPORTED, AND NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8570647 ↗
• MalfunctionMay 1, 2019Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED INDICATING THAT IMMEDIATELY ON USE, THE SMITHS MEDICAL CADD ACCESSORY KEPT ON BREAKING AND ULTIMATELY FALLING OUT. THE REPORTER INDICATED THAT REPLACEMENT OF THE LOCKS DID NOT SOLVE THE ISSUE, AND THAT THE LOCK BOXES WERE FAULTY. THE REPORTER ALSO INDICATED THAT THE PATIENT HAD REMOVED THE MEDICATION AND STAFF CAUGHT THEM. NO PATIENT CONSEQUENCES WERE REPORTED, AND NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8570646 ↗
• MalfunctionOct 25, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE DEVICE WAS IN USE WITH PATIENT FOR INFUSION OF NARCOTIC. REPORTER STATED THE PATIENT WAS ABLE TO BREAK INTO THE LOCKBOX WITHOUT KEY BY MANIPULATING THE CASING AND THE PINS HOLDING THE DOOR CLOSED. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8006274 ↗
• MalfunctionOct 15, 2018Defective Device; Defective Device

  INFORMATION WAS RECEIVED THAT THE CADD SOLIS LOCKBOX WAS ABLE TO BE OPENED WITHOUT A KEY BY PUSHING ON THE SIDE OF THE BOX. NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7964890 ↗