MiniCap EZPC4466 (UDI 00085412656021)Recalls & reported problems
Baxter Healthcare Corporation · This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set. · Class 2
Quick summary
This Baxter MiniCap is a small plastic disconnect cap with an iodine swab, used to protect the connector on peritoneal dialysis transfer sets. The 30 reports mostly describe the cap not working as intended: caps cracking, breaking, leaking fluid or iodine, coming apart, and dried-out or expired iodine, sometimes found before use and sometimes during treatment. No deaths and no injuries were reported. 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
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00085412656021), received between Jun 14, 2024 and Dec 23, 2025 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (8 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
- Product Quality Problem8
- Break4
- Fluid/Blood Leak4
- Leak/Splash3
- Crack2
- Detachment of Device or Device Component2
- Tear, Rip or Hole in Device Packaging2
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF MINICAPS LEAKED. THIS OCCURRED 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 23877663 ↗MalfunctionDec 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS A SMALL PIECE OF PAPER AT THE BOTTOM OF THE MINICAO. THIS WAS IDENTIFIED UPON OPENING THE PACKAGING, BEFORE 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 23869886 ↗MalfunctionNov 13, 2025Crack; Leak/Splash; Crack; Leak/Splash
IT WAS REPORTED THAT THERE WAS A THIN CRACK IN TWO (2) MINICAPS WHICH RESULTED IN IODINE LEAKAGE. THIS OCCURRED BEFORE 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 23543747 ↗MalfunctionNov 12, 2025Break; Fitting Problem; Break; Fitting Problem
IT WAS REPORTED THAT FORTY-SIX (46) MINICAPS WERE DAMAGED AND COULD NOT BE CONNECTED TO THE PORT. THIS OCCURRED 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 23534495 ↗MalfunctionNov 5, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THE IODINE IN AN UNSPECIFIED QUANTITY OF MINICAPS WAS DRIED OUT. 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 23477722 ↗MalfunctionNov 5, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THE IODINE IN AN UNSPECIFIED QUANTITY OF MINICAPS WAS DRIED OUT. 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 23477642 ↗MalfunctionAug 27, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF MINICAPS WERE EXPIRED. 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 22903507 ↗MalfunctionAug 26, 2025Break; Break
IT WAS REPORTED THAT UNSPECIFIED QUANTITY OF MINICAPS WERE DEFECTIVE. THIS WAS IDENTIFIED AN UNSPECIFIED PROCESS STEP 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 22897824 ↗MalfunctionAug 13, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF MINICAPS HAD ¿DRIED IODINE¿; FURTHER DESCRIBED AS ¿WAS NOT DARK AND MOISTURE AND HAS AN ORANGE COLOR¿. THIS WAS OBSERVED DURING USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THE PATIENT INDICATED THEY WOULD NO LONGER USE THE MINICAPS FROM THIS BOX AND WILL USE A NEW BOX INSTEAD. 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 22795030 ↗MalfunctionAug 1, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT FIVE (5) UNITS OF MINICAPS LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP 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 22692112 ↗MalfunctionMay 8, 2025Break; Break
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF MINICAPS WERE BROKEN. 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 21987148 ↗MalfunctionApr 24, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF MINICAPS LEAKED. THIS WAS FURTHER DESCRIBED AS THE HOME PATIENT (HP) ¿PUT PRESSURE ON THE TOP PART OF IT AND THAT CAUSED THE MINICAP TO LEAK IODINE ALL OVER¿. THE HP RESOLVED ¿BY NOT HOLDING IT OUT AND INSTEAD LAYING AND DANGLING INTO THEIR POCKET. IT WOULD STILL LEAK JUST NOT AS MUCH.¿ THIS OCCURRED 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 21899091 ↗MalfunctionMar 20, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN A MINICAP TRANSFER SET AND A MINICAP; FURTHER DESCRIBED AS THE MINICAP ¿DID NOT TIGHTEN AND FELL OFF¿. THIS OCCURRED 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 21652851 ↗MalfunctionFeb 18, 2025Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THREE (3) MINICAPS WERE "DRIED OUT." THIS WAS OBSERVED DURING SET UP 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 21395310 ↗MalfunctionFeb 12, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF MINICAPS HAD A CONNECTION ISSUE; DESCRIBED AS ¿DID NOT STAY SECURE¿. THE OCCURRED 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 21365783 ↗MalfunctionJan 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF MINICAPS CRACK AND THE IODINE LEAKS. THIS WAS FURTHER DESCRIBED AS ¿ALL THE MINI CAPS WERE LEAKING THE SAME WAY. IT JUST CAN¿T CATCH AND IF IT JUST CATCH, IT CRACKS AND IODINE LEAKS ALL OVER NIGHT¿. IT WAS NOT SPECIFIED AT WHAT STAGE OF PERITONEAL DIALYSIS THERAPY THIS EVENT WAS IDENTIFIED. 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 21119411 ↗MalfunctionOct 24, 2024Break; Break
IT WAS REPORTED THAT SIXTY (60) MINICAPS WERE DAMAGED. THIS WAS NOTICED DURING AN UNSPECIFIED PROCESS STEP 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 20529573 ↗MalfunctionOct 24, 2024Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THE SPONGE (FOAM) OF THE MINICAP HAD ¿DRIED OUT¿. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP 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 20521230 ↗MalfunctionOct 23, 2024Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THE SPONGES OF AT LEAST THREE (3) MINICAPS WERE ¿DRIED OUT¿. 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 20518142 ↗MalfunctionOct 8, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF MINICAPS LEAKED. THERE WAS LEAKING ALL OVER THE PATIENT'S CLOTHES AND BED CAUSING STAINS. THIS OCCURRED 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 20398275 ↗MalfunctionOct 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SPONGES OF SIX (6) MINICAPS WERE COMPLETELY SEPARATED FROM THE CAP. 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 20370330 ↗MalfunctionOct 1, 2024Component Missing; Component Missing
IT WAS REPORTED THAT THE SPONGES OF AN UNSPECIFIED QUANTITY OF MINICAPS WERE MISSING. THIS WAS OBSERVED DURING SET UP 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 20344872 ↗MalfunctionOct 1, 2024Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THE SPONGES OF AN UNSPECIFIED QUANTITY OF MINICAPS WERE ¿DRIED OUT¿. THIS WAS OBSERVED DURING SET UP 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 20344853 ↗MalfunctionOct 1, 2024Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT THE PACKAGES OF AN UNSPECIFIED QUANTITY OF MINICAPS WERE DAMAGED; FURTHER DESCRIBED AS "ALUMINUM FOIL ON THE MINICAPS WAS SHRIVELING UP¿. 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 20344754 ↗MalfunctionSep 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SPONGES OF SIX (6) MINICAPS WERE COMPLETELY SEPARATED FROM THE CAP. 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 20336458 ↗
Other SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE devices
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- MINICAP WITH POVIDONE-IODINE SOLUTION 5C4466PBaxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE1 recall4 deaths347 reports
- MINICAP EXTENDED LIFE PD TRNS 5C4482ABaxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE193 reports
- UltraSet CAPD Disposable Disconnect Y-Set L5C4366Baxter Healthcare Corporation · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE100 reports
- stay.safe® 050-95012Fresenius Medical Care Holdings, Inc. · SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE1 recall48 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.