FlexiCap Disconnect Cap with Povidone-Iodine Solution 5C4456Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00085412349145), received between Jun 18, 2018 and Feb 20, 2025 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (13 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Break; Break

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF FLEXICAP DISCONNECT CAPS WERE DAMAGED. THIS WAS IDENTIFIED BEFORE USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21420569 ↗
• MalfunctionAug 21, 2024Break; Break

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF FLEXICAPS WERE FOUND BROKEN. THIS WAS NOTICED BEFORE USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015613 ↗
• MalfunctionApr 1, 2024Break; Break

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF FLEXICAPS WERE DAMAGED. THIS WAS OBSERVED PRIOR TO USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19011479 ↗
• MalfunctionFeb 15, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT FIFTEEN (15) FLEXICAP DISCONNECT CAPS LEAKED IODINE. THE EVENT WAS FURTHER DESCRIBED AS ¿POVIDONE IODINE SOLUTION NOTED TO HAVE IODINE AROUND THE SEAL WHEN OPENING THE PACKAGE." THE FLEXICAPS WERE EXPIRED. THIS WAS OBSERVED DURING USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712134 ↗
• MalfunctionAug 14, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF FLEXICAPS HAD IODINE LEAKAGE. THIS WAS OBSERVED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540548 ↗
• MalfunctionJul 27, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PACKAGING OF A FLEXICAP WAS DAMAGED; FURTHER DESCRIBED AS ¿AN ACTUAL CUT ON THE CAP PACKAGING¿. THIS WAS OBSERVED PRIOR TO USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17404940 ↗
• MalfunctionJul 11, 2023Break; Break

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF FLEXICAP DISCONNECT CAPS WERE DAMAGED. THIS WAS OBSERVED PRIOR TO USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298885 ↗
• MalfunctionMar 20, 2023Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE INDIVIDUAL PACKAGING OF A FLEXICAP WAS DAMAGED; FURTHER DESCRIBED AS ¿SEAL ON THE SIDE OF THE FLEXICAP WAS BROKEN." THIS OCCURRED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16575476 ↗
• MalfunctionOct 27, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE OVERPOUCH OF A FLEXICAP WASNOT SEALED PROPERLY . THE EVENT OCCURRED WHEN THE PATIENT RECEIVED A DAMAGED BOX OF FLEXICAPS. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15685648 ↗
• MalfunctionAug 4, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF FLEXICAPS WERE EXPIRED. THIS ISSUE WAS NOTICED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15167865 ↗
• MalfunctionJul 26, 2022Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT A MINICAP HAD NO IODINE; FURTHER DESCRIBED AS ¿THE DYE HAD NOT RELEASED AND NOTICED THE DYE HAD DRIED OUT¿. THIS WAS OBSERVED DURING USE OF THE DEVICE OF PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103537 ↗
• MalfunctionJun 13, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE STERILE PACKAGING OF AN UNSPECIFIED QUANTITY OF FLEXICAPS WERE DAMAGED. THE PATIENT RECEIVED DAMAGED SHIPPING BOXES WHICH ALSO CONTAINED DAMAGED PRODUCT INSIDE. THIS WAS OBSERVED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675772 ↗
• MalfunctionMay 21, 2022Break; Break

  IT WAS REPORTED THAT A FLEXICAP DISCONNECT CAP HAD "DAMAGED OPENED BOX AND THE FLEXICAPS INSIDE WERE DIRTY AND UNUSABLE". THIS WAS OBSERVED BEFORE USE OF PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14465773 ↗
• MalfunctionMay 13, 2022Break; Break

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF FLEXICAPS WERE RECEIVED IN DAMAGED CONDITION. THE DAMAGED FLEXICAPS WERE DISCOVERED UPON DELIVERY. IT WAS NOT SPECIFIED IF THE PRODUCT WAS USED BY A PATIENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14398945 ↗
• MalfunctionMay 10, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING OF AN UNSPECIFIED QUANTITY OF MINICAPS WAS DAMAGED; FURTHER DESCRIBED AS "INDIVIDUAL POUCHES WERE OPENED". THIS WAS FOUND BEFORE USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY . THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345663 ↗
• MalfunctionMay 4, 2022Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PACKAGING OF AN UNSPECIFIED QUANTITY OF FLEXICAPS WERE DAMAGED. THE DAMAGED PACKAGING WAS FURTHER DESCRIBED AS, ¿THERE WERE PIN HOLES IN THE OVERWRAPPING OF THE FLEXICAPS. THEY STATED THAT SOME OF THE FLEXICAPS LOOKED LIKE THEY HAD BEEN OPENED AND RETAPED. THE CUSTOMER REPORTED THAT THE OUTSIDE OF THE OF THE FLEXICAP OVERWRAPPING WAS DIRTY¿. THIS OCCURRED BEFORE USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14272625 ↗
• MalfunctionApr 21, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE INDIVIDUAL PACKAGING OF AT LEAST FIVE (5) FLEXICAPS WERE DAMAGED (OPENED). THIS WAS OBSERVED BEFORE USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14173000 ↗
• MalfunctionFeb 14, 2022Break; Break

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF FLEXICAPS WERE DAMAGED. THIS WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP OF PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13525408 ↗
• MalfunctionOct 25, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT POUCHES OF AN UNSPECIFIED QUANTITY OF FLEXICAPS WERE OPENED. THIS WAS OBSERVED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12692310 ↗
• MalfunctionOct 25, 2021Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT FOUR (4) FLEXICAPS WERE DAMAGED; FURTHER DESCRIBED AS "FOUR (4) PACKAGES WERE OPENED". THIS WAS OBSERVED BEFORE USE OF PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12689227 ↗
• MalfunctionSep 14, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE STERILE INDIVIDUAL PACKAGING OF A FLEXICAP WAS DAMAGED. THE DAMAGE WAS FURTHER DESCRIBED AS ¿CAP WAS OPEN, AND IT APPEARS TO HAVE BEEN STEPPED ON OR RUN OVER CAUSING THE CAP TO PUNCTURE THE PACKAGE¿. THIS WAS OBSERVED BEFORE USE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12471977 ↗
• MalfunctionSep 1, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE INDIVIDUAL PACKAGING OF AT LEAST FIVE (5) FLEXICAPS WERE DAMAGED. THE DAMAGE WAS FURTHER DESCRIBED AS "SPLIT OPEN". THIS WAS OBSERVED BEFORE USE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408666 ↗
• MalfunctionAug 20, 2021Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE STERILE PACKAGING OF SIX (6) FLEXICAPS WERE DAMAGED. THE SHIPPING BOX WAS DELIVERED DAMAGED AND RIPPED OPEN AND IT APPEAR THAT SOME FLEXICAPS WERE RIPPED OPEN A LITTLE AND OTHERS WERE IN QUESTION. THIS WAS DISCOVERED PRIOR TO USE FOR PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12350806 ↗
• MalfunctionMay 28, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT STERILE PACKAGING OF AN UNSPECIFIED QUANTITY OF PERITONEAL DIALYSIS (PD) FLEXICAPS WERE DAMAGED/TORN. THE DAMAGE WAS FURTHER DESCRIBED AS A, ¿BIG HOLE ON THE SIDE AND HAVE BEEN PIERCED¿. THIS WAS OBSERVED BEFORE USE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11901178 ↗
• MalfunctionMay 19, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF FLEXICAPS WERE DAMAGED; FURTHER DESCRIBED AS "THE CAP RIPPED THROUGH THE PLASTIC". THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848324 ↗