Midstream Urine Collector 842904Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741051227), received between Feb 25, 2021 and Jun 18, 2021 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE CUSTOMER HAD ONE CASE OF DEFECTIVE MIDSTREAM WHERE THE GLUE WAS NOT KEEPING THE ITEM SEALED. PER FOLLOW UP ON 26MAY2021, CUSTOMER STATED PRODUCT BOX LID THAT WAS GLUED TO KEEP THE PRODUCT SEALED WAS NOT HOLDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12024685 ↗
• MalfunctionJun 17, 2021Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE CATHETERS HAD DEFECTIVE MIDSTREAM WERE THE GLUE WAS NOT KEEPING THE ITEM SEALED. PER ADDITIONAL INFORMATION ON 26MAY2021, CUSTOMER STATED PRODUCT BOX LID THAT WAS GLUED TO KEEP THE PRODUCT SEALED WAS NOT HOLDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12014294 ↗
• MalfunctionMay 4, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE GLUE CLOSING THE OUTER BOX WAS NOT STAYING SEALED IN TWO CASES OF MIDSTREAM CLEAN CATCH. THE NURSE FEELS THAT THE INNER CONTENTS HAD BEEN COMPROMISED WITH THE LID BEING OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769230 ↗
• MalfunctionApr 23, 2021Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT UPON TWO CASES OF THE MIDSTREAM CLEAN CATCH, THE GLUE CLOSING THE OUTER BOX WAS NOT STAYING SEALED AND THE LID WAS BEING OPENED. THE NURSE FELT THAT THE INNER CONTENT HAD BEEN COMPROMISED. PER FOLLOW UP ON 19APR2021, THE CUSTOMER NOTED THAT THE GLUE ON THE INNER BOX WITH THE CONTENTS IS NOT STAYING ADHERED SO WHEN THEY OPEN THE CASE, THE INDIVIDUAL BOXES ARE WIDE OPEN. PER CUSTOMER VIA PHONE ON 19APR2021, ALL KNOWN INFORMATION REGARDING THE EVENT HAS BEEN REPORTED AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11719197 ↗
• MalfunctionApr 23, 2021Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE GLUE CLOSING THE OUTER BOX WAS NOT STAYING SEALED IN TWO CASES OF MIDSTREAM CLEAN CATCH. THE NURSES FEEL THAT THE INNER CONTENTS HAD BEEN COMPROMISED WITH THE LID BEING OPENED. FURTHER REPORTED SAME ISSUES ON 18-MAR-2021, 29-MAR-2021AND 09-APR-2021. PER FOLLOW-UP RESPONSE ON 23APR2021 THAT TWO CASES OF MIDSTREAM CLEAN CATHETER PRODUCT WAS RETURNED ON 23APRIL2021 USING LABELS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11718551 ↗
• MalfunctionApr 20, 2021Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT UPON TWO CASES OF THE MIDSTREAM CLEAN CATCH, THE GLUE CLOSING THE OUTER BOX WAS NOT STAYING SEALED AND THE LID WAS BEING OPENED. THE NURSE FEELS THAT THE INNER CONTENT HAD BEEN COMPROMISED. PER FOLLOW UP ON (B)(6) 2021, THE CUSTOMER NOTED THAT THE GLUE ON THE INNER BOX WITH THE CONTENTS IS NOT STAYING ADHERED SO WHEN THEY OPEN THE CASE, THE INDIVIDUAL BOXES ARE WIDE OPEN. PER CUSTOMER VIA PHONE ON (B)(6) 2021, ALL KNOWN INFORMATION REGARDING THE EVENT HAS BEEN REPORTED AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693094 ↗
• MalfunctionFeb 25, 2021Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE GLUE TO CLOSE THE BOX WAS NOT STICKING, WHICH LEFT THE CONTENTS IN THE BOX EXPOSED. PER FOLLOW UP VIA PHONE ON 24FEB2021, THE CUSTOMER NOTED THAT THE PROBLEM WAS WITH THE BOX CONTAINING THE CLEAN CATCH KIT AND NOT THE SHIPPING BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11378528 ↗