Empty Sterile Container 5C4462Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00085412007670), received between Jul 17, 2023 and Jul 18, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 18, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EMPTY STERILE CONTAINER LEAKED; FURTHER DESCRIBED AS "LEAKAGE FOUND AT THE CONNECTION SITE" AND "A TEAR WAS SEEN ON CLOSE OBSERVATION". THIS OCCURRED DURING USE OF THE DEVICE 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 17341724 ↗
• MalfunctionJul 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A EMPTY STERILE CONTAINER LEAKED. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT, HOWEVER THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17336624 ↗
• MalfunctionJul 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THREE (3) EMPTY STERILE CONTAINERS LEAKED. THIS OCCURRED 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 17336257 ↗
• MalfunctionJul 17, 2023Crack; Crack

  IT WAS REPORTED THAT AN EMPTY STERILE CONTAINER HAD A CRACKED IN THE CONNECTION PORT. THIS WAS OBSERVED BEFORE USE OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17335688 ↗