Locking Titanium Adapter for Peritoneal Dialysis Catheter 5C4129 (UDI 00085412007403)Recalls & reported problems
Baxter International Inc. · This adapter is a double sealing female Luer lock adapter with a 2-piece, combination compression fit/barbed catheter connector. The adapter is used to connect the PD catheter to a solution transfer set with locking connector. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Baxter titanium adapter connects a peritoneal dialysis catheter to the transfer set used in dialysis fluid exchange. The 45 reports mostly describe the connection coming apart during use, fluid or blood leaking at the joint, connectors that don't seat properly, and torn or unsealed packaging. There are no deaths and one injury. 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
- 45
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00085412007403), received between Apr 23, 2018 and Jan 20, 2026 — classified as 1 injury, 44 malfunctions.
The most frequently reported specific device problem is “Disconnection” (11 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.
Reports received per month
Most reported problems
Device problems
- Disconnection11
- Fluid/Blood Leak8
- Incomplete or Inadequate Connection5
- Tear, Rip or Hole in Device Packaging5
- Fitting Problem4
- Unsealed Device Packaging4
- Delivered as Unsterile Product3
- Loose or Intermittent Connection3
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- No Patient Involvement12
- No Consequences Or Impact To Patient6
- Peritonitis1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A FLUID LEAK BETWEEN THE BODY AND SLEEVE OF A TITANIUM ADAPTER. 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 24118362 ↗MalfunctionDec 31, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A LEAK BETWEEN THE MINICAP TRANSFER SET AND TITANIUM ADAPTER. THIS OCCURRED DURING USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THE TITANIUM ADAPTER WAS REPLACED AND THE ISSUE RESOLVED. 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 23934172 ↗MalfunctionNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS A LEAK AT THE CONNECTION OF THE MINICAP TRANSFER SET AND TITANIUM ADAPTER. 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 23466596 ↗MalfunctionNov 3, 2025Device Damaged Prior to Use; Device Damaged Prior to Use
IT WAS REPORTED THAT A LOCKING TITANIUM ADAPTER HAD A DAMAGED POUCH. THIS WAS OBSERVED 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 23452165 ↗MalfunctionAug 25, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN A TITANIUM ADAPTER AND TRANSFER SET. THE TITANIUM ADAPTER DISCONNECTED FROM THE TRANSFER SET. THIS OCCURRED DURING USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THE TITANIUM ADAPTER AND TRANSFER SET WERE REPLACE. 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 22883354 ↗MalfunctionJul 14, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE TITANIUM ADAPTER AND NON-VANTIVE CATHETER; FURTHER DESCRIBED AS "THE CATHETER CAN BE PULLED OUT AFTER CONNECTING TO TITANIUM ADAPTER." 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 22494630 ↗MalfunctionJul 14, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE TITANIUM ADAPTER AND NON-VANTIVE CATHETER; FURTHER DESCRIBED AS "THE CATHETER CAN BE PULLED OUT AFTER CONNECTING TO TITANIUM ADAPTER." 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 22494617 ↗MalfunctionJul 14, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE TITANIUM ADAPTER AND NON-VANTIVE CATHETER; FURTHER DESCRIBED AS "THE CATHETER CAN BE PULLED OUT AFTER CONNECTING TO TITANIUM ADAPTER." 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 22494463 ↗MalfunctionJul 14, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE TITANIUM ADAPTER AND NON-VANTIVE CATHETER; FURTHER DESCRIBED AS "THE CATHETER CAN BE PULLED OUT AFTER CONNECTING TO TITANIUM ADAPTER." 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 22494405 ↗MalfunctionJul 14, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN TWO (2) TITANIUM ADAPTERS AND THE NON-VANTIVE CATHETER; FURTHER DESCRIBED AS "THE CATHETER CAN BE PULLED OUT AFTER CONNECTING TO TITANIUM ADAPTER." 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 22494404 ↗MalfunctionMay 9, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE TITANIUM ADAPTER AND NON-VANTIVE CATHETER; FURTHER DESCRIBED AS "THE TITANIUM CONNECTOR DETACHED FROM THE CATHETER." THIS OCCURRED DURING TESTING OF THE DEVICE IN WHICH LIGHT TRACTION WAS APPLIED BETWEEN THE TITANIUM ADAPTER AND NON-VANTIVE CATHETER. A PERI-PATCH REPAIR WAS COMPLETED. 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 21995985 ↗MalfunctionMay 9, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE TITANIUM ADAPTER AND NON-VANTIVE CATHETER; FURTHER DESCRIBED AS "THE TITANIUM CONNECTOR DETACHED FROM THE CATHETER." THIS OCCURRED FOUR DAYS AFTER A CATHETER REPAIR PROCEDURE IN WHICH A NEW TITANIUM ADAPTER WAS INSTALLED. THE REPAIR PROTOCOL WAS REPEATED AND A NEW TITANIUM ADAPTER WAS INSTALLED. 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 21995984 ↗MalfunctionFeb 19, 2025Connection Problem; Connection Problem
IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE WITH THE TITANIUM ADAPTER. 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 21411082 ↗MalfunctionAug 13, 2024Disconnection; Disconnection
IT WAS REPORTED THAT A TITANIUM ADAPTER DISCONNECTED FROM THE CATHETER; FURTHER DESCRIBED AS "THE TITANIUM JOINT AND CATHETER FELL OFF." 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, HOWEVER THE PATIENT WAS PROVIDED ANTIBIOTIC TREATMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19972460 ↗MalfunctionJun 17, 2024Fitting Problem; Fitting Problem
IT WAS REPORTED THAT A TITANIUM ADAPTER HAD A CONNECTION ISSUE; FURTHER DESCRIBED AS ¿CANNOT CONNECTED TO THE NON-BAXTER CATHETER¿. THIS OCCURRED DURING CATHETER SURGERY INSERTION. THE TITANIUM ADAPTER WAS REPLACED AND THE ISSUE RESOLVED. 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 19547659 ↗MalfunctionAug 16, 2023Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT THE INDIVIDUAL PACKAGING OF THE TITANIUM ADAPTER WAS BROKEN. THIS WAS OBSERVED BEFORE USE OF THE DEVICE PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17556155 ↗MalfunctionNov 11, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PACKAGING (OVERPOUCH) OF A LOCKING TITANIUM ADAPTER WAS CRACKED. THIS WAS OBSERVED DURING PREPARATION OF THE DEVICE BEFORE PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15782414 ↗MalfunctionOct 24, 2022Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT A LOCKING TITANIUM ADAPTER "HAD BODY AND SLEEVE UNABLE TO BE CONNECTED TIGHTLY." THIS ISSUE WAS NOTICED 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 15658048 ↗MalfunctionSep 24, 2022Disconnection; Disconnection
IT WAS REPORTED THAT THERE WAS A DISCONNECTION BETWEEN A TITANIUM ADAPTER AND A MINICAP EXTENDED LIFE PD TRANSFER SET. 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 15479166 ↗InjuryJul 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED FLUID LEAKAGE BETWEEN THE TITANIUM ADAPTER AND THE PD CATHETER DURING USE. SUBSEQUENTLY THE PATIENT DEVELOPED PERITONITIS MANIFESTED BY CLOUDY FLUID. THE CAUSE OF THE LEAKAGE WAS NOT REPORTED. THE TITANIUM ADAPTER AND TRANSFER SET WERE REPLACED IMMEDIATELY. THE PATIENT WAS HOSPITALIZED FOR THE EVENT AND WAS TREATED WITH GENTAMICIN AND "ABDOMINAL DIALYSIS LIQUID FLUSHING ABDOMINAL TREATMENT". THREE DAYS AFTER EVENT ONSET, THE PATIENT WAS DISCHARGED IN "GOOD CONDITION". NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Peritonitis
MAUDE report 15069846 ↗MalfunctionJun 22, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE PACKAGE OF A TITANIUM ADAPTER WAS DAMAGED. 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 14778850 ↗MalfunctionMay 26, 2022Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT THE LOCKING TITANIUM ADAPTER DISCONNECTED FROM A TRANSFER SET RESULTING IN A LEAK; FURTHER DESCRIBED AS THE TRANSFER SET "FALLING OFF". THIS ISSUE WAS NOTICED DURING AN UNSPECIFIED PROCESS STEP OF PERITONEAL DIALYSIS THERAPY. THE LEAK WAS FURTHER DESCRIBED AS ¿LEAKING PD FLUID FROM THE END OF THEIR PD CATHETER". 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 14519487 ↗MalfunctionMay 26, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE LOCKING TITANIUM ADAPTER LEAKED. THIS ISSUE WAS NOTICED DURING PATIENT USE 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 14517807 ↗MalfunctionApr 5, 2022Break; Tear, Rip or Hole in Device Packaging; Break; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PACKAGING OF A TITANIUM ADAPTER WAS ¿BROKEN¿. 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 14016050 ↗MalfunctionAug 9, 2021Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT THE TITANIUM ADAPTER PACKAGING WAS OPENED. 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 12294433 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page