Clear Advantage Spirit Adhesive SheathRecalls & reported problems across all models

We found 6 models of Clear Advantage Spirit Adhesive Sheath by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Aug 24, 2017 and Dec 22, 2023 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Clear Advantage Spirit Adhesive Sheath problems

Clear Advantage Spirit Adhesive Sheath models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Clear Advantage Spirit Adhesive Sheath 7283

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  7 reports
• Clear Advantage Spirit Adhesive Sheath 7323

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  5 reports
• Clear Advantage Spirit Adhesive Sheath 5283

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  3 reports
• Clear Advantage Spirit Adhesive Sheath 7243

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  3 reports
• Clear Advantage Spirit Adhesive Sheath 5323

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  2 reports
• Clear Advantage Spirit Adhesive Sheath 5243

  DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
  1 report

Recent Clear Advantage Spirit Adhesive Sheath adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER SHEATHS WERE COMING OFF AT THE BASE OF THE PENIS AND THAT AREA HAD ALSO BEEN GETTING A BIT SORE. SOMETIMES THE WHOLE PENIS HAD BEEN SORE, AND THE GENERAL PRACTITIONER PRESCRIBED A CREAM. THE SHEATHS WERE NOT USED WHILE SORE AND CONFIRMED THAT THE AREA WAS COMPLETELY DRY. THE PATIENT WAS USING A SIMPLE SOAP AND WAS SUGGESTED IMPERIAL LEATHER. THEY WERE NOT USING WET WIPES AND WERE ADVISED TO USE DRY WIPES AND KITCHEN TOWELS.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 18382771 ↗
• MalfunctionMar 29, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER THOUGHT THAT THEY WERE DOING SOMETHING WRONG WHEN THEY WERE UNABLE TO CONNECT A BAG TO THE MALE EXTERNAL CATHETER. THE REPRESENTATIVE WENT TO HELP AND FOUND A FAULTY SHEATH. ONE OF THE MALE EXTERNAL CATHETER WAS FOUND TO BE HAVING THE OUTLET ON THE FUNNEL OF THE SHEATH CLOSED OFF. THE OUTLET SHOULD BE OPEN TO ALLOW URINE TO DRAIN. THEY CHECKED ALL OTHER SHEATHS IN THE BOX AND FOUND THAT OTHER SHEATHS WERE OKAY. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON 22MAR2022, IT WAS STATED THAT THE DEFECT FOUND WHILE BEING USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16637405 ↗
• MalfunctionMar 16, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETERS WERE ROLLING UP AND CAUSING LEAKING. ALSO STATED THAT THEY WERE HAVING PROBLEMS TAKING THE SHEATHS OFF AS THEY WERE SO ADHESIVE AND WERE TOO STICKY. THE PATIENT STATED THAT THIS HAD RESULTED IN BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 16554295 ↗
• MalfunctionDec 27, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD NOTICED A CHANGE IN THE PACKAGING OF THEIR SHEATH. THE WHITE PLASTIC WAS A LOT THINNER AND ON THE CLEAR PLASTIC SIDE IT WAS VERY THIN AND VACUUM WAS PACKED AROUND THE SHEATH. THEY ALSO FELT THAT THE SHEATH ITSELF WAS INFERIOR TO WHAT THEY HAD BEEN USING WITH AND WERE COMING OFF MORE FREQUENTLY. AS PER SAMPLE EVALUATION RESULTS RECEIVED ON (B)(6) 2022, STATED THAT THE STRONG ADHESIVE WAS FOUND DURING SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052462 ↗
• MalfunctionNov 8, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON THIS PRODUCT WAS SO STICKY THAT IT LEFT PEELS OF ADHESIVE ON THE PATIENT'S SHEATH AREA, PLUS THE ROLL DOWN WAS INEFFECTIVE AT WRAPPING AROUND THE PENIS TO WORK PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15752788 ↗
• MalfunctionMay 23, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THIS BATCH OF MALE EXTERNAL SHEATHS SEEMED TO HAVE MORE ADHESIVE THAN USUAL AND WERE HARD TO TAKE OFF. AS PER THE FOLLOW-UP INFORMATION RECEIVED VIA IBC ON 17MAY2022, IT WAS STATED THAT THERE WAS NO IMPACT TO THE PATIENT AND IT WAS JUST HARDER TO TAKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14473917 ↗
• MalfunctionMar 10, 2022Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT WHEN THE MALE EXTERNAL SHEATHS WERE TAKEN OUT OF BOX, THE GLUE WAS CONGEALED AND SHEATHS SEEMED UNUSABLE. IT WAS ALSO STATED THAT THE SHEATHS FROM THE SAME LOT WERE KEPT ON POPPING OFF AT NIGHT AND HAD TO PUT ON 4 NEW SHEATHS AS THEY WOULD NOT STAY ON. PER FOLLOW UP VIA IBC ON 22FEB2022, THE SHEATHS WERE STUCK TO THEMSELVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721125 ↗
• MalfunctionMar 4, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE ADHESIVE ON HALF OF THE MALE EXTERNAL SHEATHS HAD SEEMED TO BE MELTED. THEY WERE STICKING TO INSIDE OF THE PACKETS WHICH MADE DIFFICULT TO TAKE THE SHEATHS OUT, BUT WHEN FITTED THEY WERE UNCOMFORTABLE TO THE PATIENT. THE SHEATHS ALSO LEFT BLACK ADHESIVE ON THE PENIS WHEN REMOVED AND CAUSED THE PATIENT TO GO THROUGH DOUBLE THEIR ADHESIVE REMOVER JUST TO GET THEM OFF. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP VIA IBC ON 28-FEB-2022, THE PATIENT USED TWICE THE AMOUNT OF ADHESIVE REMOVER AND SO IT WAS MADE SURE THE PENIS WAS CLEAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13666974 ↗
• MalfunctionJun 21, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT PATIENT ORDERED MALE EXTERNAL CATHETERS WHICH WERE FAULTY, AS IT WAS ROLLING THEM ON THEY KEPT GETTING CRUMPLED UP, CAUSING AIR BUBBLES ON ONE SIDE AND THEN HAD A DIFFICULT TIME REMOVING THEM WITH THE ADHESIVE REMOVER SPRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12035464 ↗
• MalfunctionDec 15, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE MALE EXTERNAL CATHETER HAD TOO MUCH ADHESIVE ON THE TOP OF THE SHEATH WHEN COMPARED WITH THE REST OF THE SHEATHS. THE PATIENT ALSO REPORTED OF A DRAINING ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11006489 ↗
• MalfunctionDec 7, 2020Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT WAS STRUGGLING TO GET THE MALE EXTERNAL CATHETER OFF AND STATED THERE WAS A FAULT WITH THE SHEATHS. IT WAS ALSO STATED THAT THE USER HAD THE SAME ISSUE WITH THE SAME PRODUCT AND LOT NUMBER WITH 2 DIFFERENT CUSTOMERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10962228 ↗
• MalfunctionApr 3, 2020Leak/Splash; Nonstandard Device; Difficult to Remove; Nonstandard Device

  IT WAS REPORTED THAT SOME OF THE SHEATHS STUCK SO FAST, THAT THEY STRUGGLED TO REMOVE THEM EVEN WITH THE SPRAY AND WARM WATER. SHE WAS UNSURE WHY THIS HAPPENED, BUT SHE WAS UNCOMFORTABLE USING SO MUCH OF THE SPRAY AS SHE WAS CONCERNED WHAT IT WOULD DO TO THE PATIENTS' SKIN. IT WAS ALSO REPORTED THAT THE SHEATHS WERE ALSO COMING OFF, AND BARELY LASTED HALF THE NIGHT. IT WAS UNCLEAR IF IT WAS BECAUSE OF THE AMOUNT OF URINE THAT WAS FLOWING BACK FROM THE LEG BAG, AND THE PATIENT WONDERED IF IT COULD BE DISSOLVING THE ADHESIVE ON THE SHEATHS.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9923643 ↗
• MalfunctionMay 10, 2018Nonstandard Device; Nonstandard Device; Difficult to Remove; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE SHEATHS WERE COVERED IN TOO MUCH ADHESIVE SO MUCH SO THEY ARE DIFFICULT TO REMOVE AND ARE CAUSING DAMAGE TO THE PATIENT'S SKIN ON LEGS WHERE THEY TOUCH THE ADHESIVE. IT GETS ON THE PATIENTS CLOTHING AND THEY ARE MUCH MORE DIFFICULT TO UNROLL. PER ADDITIONAL INFORMATION THE SKIN WAS NOT DAMAGED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7502651 ↗
• MalfunctionDec 19, 2017Output above Specifications

  IT WAS REPORTED THAT DURING THE SAMPLE EVALUATION OF THE INVESTIGATION, TWO OF THOSE SAMPLES TESTED ABOVE SPECIFICATION FOR STRONG ADHESIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7131921 ↗
• MalfunctionDec 18, 2017Output above Specifications

  IT WAS REPORTED THAT DURING THE SAMPLE EVALUATION OF THE INVESTIGATION, TWO OF THOSE SAMPLES TESTED ABOVE SPECIFICATION FOR STRONG ADHESIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7127459 ↗

Other C. R. Bard, Inc. products

• Bardex I.C. Foley Catheter26 models · 3,607 reports
• Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
• Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
• Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
• Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
• Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
• PureWick Female External Catheter5 models · 1,184 reports
• Bardex All-Silicone Foley Catheter12 models · 1,170 reports