RAPIDFILL H93813901Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00085412478364), received between Jul 26, 2019 and Dec 11, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (20 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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A RAPIDFILL CONNECTORS HAD PARTICLE (DUST TYPE) INSIDE THE STERILE PACKAGING OF THE DEVICE. THE ISSUE WAS NOTICED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23779608 ↗
• MalfunctionSep 11, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A RAPIDFILL CONNECTOR HAD FOREIGN PARTICULATE MATTER. FTIR (FOURIER TRANSFORM INFRARED SPECTROSCOPY) IDENTIFIED CELLULOSE, HIGH DENSITY POLYETHYLENE, AND DRIED BLACK INK PARTICULATE INSIDE THE FINISHED PRODUCT THAT THIS DEVICE WAS USED WITH DURING THE COMPOUNDING PROCESS. THE PARTICULATES WERE OBSERVED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195857 ↗
• MalfunctionSep 11, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A RAPIDFILL CONNECTOR HAD FOREIGN PARTICULATE MATTER. FTIR (FOURIER TRANSFORM INFRARED SPECTROSCOPY) IDENTIFIED POLYESTER FIBER, COTTON, CELLULOSE, POLY ETHYL ACRYLATE WOOL, HIGH DENSITY POLYETHYLENE, AND POLYSTYRENE PARTICULATE INSIDE THE FINISHED PRODUCT THAT THIS DEVICE WAS USED WITH DURING THE COMPOUNDING PROCESS. THE PARTICULATES WERE OBSERVED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195823 ↗
• MalfunctionSep 11, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A RAPIDFILL CONNECTOR HAD FOREIGN PARTICULATE MATTER. FTIR (FOURIER TRANSFORM INFRARED SPECTROSCOPY) IDENTIFIED COTTON PARTICULATE INSIDE THE FINISHED PRODUCT THAT THIS DEVICE WAS USED WITH DURING THE COMPOUNDING PROCESS. THE PARTICULATES WERE OBSERVED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195650 ↗
• MalfunctionSep 11, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A RAPIDFILL CONNECTOR HAD FOREIGN PARTICULATE MATTER. FTIR (FOURIER TRANSFORM INFRARED SPECTROSCOPY) IDENTIFIED CELLULOSE, TRILENE, OLEFIN, AND NYLON FIBER PARTICULATE INSIDE THE FINISHED PRODUCT THAT THIS DEVICE WAS USED WITH DURING THE COMPOUNDING PROCESS. THE PARTICULATES WERE OBSERVED DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195593 ↗
• MalfunctionOct 13, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN EYELASH WAS OBSERVED INSIDE A RED RAPIDFILL CONNECTOR. THIS WAS OBSERVED WHEN THE NURSE WENT TO OPEN THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17932641 ↗
• MalfunctionNov 8, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PARTICLE WAS OBSERVED INSIDE THE RAPIDFILL CONNECTORS (RED). THIS WAS OBSERVED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15755207 ↗
• MalfunctionAug 31, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHITE SPECS WERE OBSERVED ON AN UNSPECIFIED QUANTITY OF RAPIDFILL CONNECTORS (RED). THIS WAS OBSERVED WHEN OPENING THE PACKAGING, PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331593 ↗
• MalfunctionAug 31, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT WHITE SPECS WERE OBSERVED ON AN UNSPECIFIED QUANTITY OF RAPIDFILL CONNECTORS (RED). THIS WAS OBSERVED WHEN OPENING THE PACKAGING, PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15331589 ↗
• MalfunctionAug 3, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PARTICULATE MATTER (PM) WAS OBSERVED ON THE CONNECTOR OF AN UNSPECIFIED QUANTITY OF RAPIDFILL CONNECTORS. THE PM WAS FURTHER DESCRIBED AS, ¿SMALL BLACK FLAKES ON CONNECTOR¿. THE PM WAS OBSERVED DURING PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15157544 ↗
• MalfunctionAug 3, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PARTICULATE MATTER (PM) WAS OBSERVED ON THE CONNECTOR OF AN UNSPECIFIED QUANTITY OF RAPIDFILL CONNECTORS. THE PM WAS FURTHER DESCRIBED AS, ¿SMALL BLACK FLAKES ON CONNECTOR¿. THE PM WAS OBSERVED DURING PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15157542 ↗
• MalfunctionAug 24, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF RAPIDFILL CONNECTORS (RED) WHERE CONTAMINATED WITH PARTICULATE MATTER (PM). THE PM WAS FURTHER DESCRIBED AS BLACK OR WHITE SPOTS. SOME PM WAS WITHIN THE STERILE PACKAGING AND SOME WAS BETWEEN THE SEAL OF THE PACKAGING. IT WAS FURTHER REPORTED THAT THE PM APPEARED TO BE MOSTLY LOOSE. THIS WAS DISCOVERED DURING PRODUCTION, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12359574 ↗
• MalfunctionJan 14, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A ¿DEAD BUG (GNAT LIKELY)¿ WAS OBSERVED INSIDE A SEALED RAPIDFILL CONNECTOR. THIS WAS IDENTIFIED DURING SETUP AND PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 11173029 ↗
• MalfunctionNov 24, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS FOREIGN MATTER CONTAMINATION OBSERVED ON THE CENTER LOCK OF THE OF THE RAPIDFILL CONNECTOR. THE FOREIGN MATTER WAS FURTHER DESCRIBED AS A ¿BLACK DOT¿ ON THE LOCK INSIDE AND WAS NOT EMBEDDED. THE FOREIGN MATTER WAS DISCOVERED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10896799 ↗
• MalfunctionNov 9, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DARK PARTICULATE MATTER WAS OBSERVED IN THE FLUID PATH OF TWO (2) RAPID FILL CONNECTORS. THIS ISSUE WAS IDENTIFIED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10813764 ↗
• MalfunctionJul 29, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A BLACK PARTICULATE MATTER WAS OBSERVED IN THE PRIMARY PACKAGING OF A RAPIDFILL CONNECTOR. THIS WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10338298 ↗
• MalfunctionJun 19, 2020Delivered as Unsterile Product; Device Contamination with Chemical or Other Material; Delivered as Unsterile Product; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE PACKAGING OF EIGHTY (80) RAPIDFILL CONNECTORS WERE WET. THIS WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10176392 ↗
• MalfunctionJun 12, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF RAPIDFILL CONNECTORS CONTAINED PARTICULATE MATTER (DARK) ¿THAT DID NOT APPEAR EMBEDDED¿. THIS WAS IDENTIFIED DURING INSPECTION PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10150531 ↗
• MalfunctionJun 12, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF RAPIDFILL CONNECTORS CONTAINED PARTICULATE MATTER (DARK) ¿THAT DID NOT APPEAR EMBEDDED¿. THIS WAS IDENTIFIED DURING INSPECTION PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10150529 ↗
• MalfunctionJul 26, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT TWO RAPIDFILL CONNECTORS HAD PARTICULATE MATTER. ONE DEVICE HAD A SMALL DARK PARTICLE INSIDE THE WALL OF THE CONNECTOR, AND ONE DEVICE HAD A FIBROUS STRAND IN THE PACKAGING. NO PATIENTS WERE INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8831773 ↗