PCA 602103Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10887787001904), received between Aug 22, 2018 and Oct 11, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Particulates” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2024Particulates; Particulates

  THE COMPLAINT/EVENT OCCURRED ON UNSPECIFIED DATES AND INVOLVED A EMPTY PCA VIAL WITH INJECTOR. THE REPORTER STATED THAT THE VIALS HAD PARTICULATE MATTER OR OTHER DEFECTS. THE PROCESS REQUIRES INSPECTION OF STARTING MATERIALS DURING DIFFERENT STAGES OF MATERIAL TRANSFER. THE EVENT OCCURRED OVER THE COURSE OF MONTHS. THE CUSTOMER ALLEGED PARTICULATES IN THE VIAL, IN THE PACKAGING, AND OTHER GENERALIZED DEFECTS. IT IS UNKNOWN HOW MANY VIALS WERE ALLEGED TO HAVE CONTAMINATION WITHIN THE VIAL; HOWEVER, A TOTAL OF 2000 WERE REPORTED AS DEFECTIVE FOR ANY OF THE AFOREMENTIONED FAILURE MODES. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433294 ↗
• MalfunctionAug 15, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A EMPTY PCA VIAL WITH INJECTOR THAT REPORTEDLY CONTAINED PARTICULATE MATTER INSIDE THE VIAL AND ALSO IN THE PACKAGING. THE PARTICULATES WERE FOUND IN THE EMPTY UNIT PRIOR TO PRODUCTION, AS WELL AS IN POST-PRODUCTION DURING VISUAL INSPECTION. THE CUSTOMER REPORTED FINDINGS OF CARDBOARD, ORGANIC MATERIALS AND DIFFERENT COLORED FIBERS AND CONSIDERED THIS TO BE VALID AS THESE WERE FOUND DURING VISUAL TESTING ON THEIR SITE. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE REACTION AND NO NEED FOR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990502 ↗
• MalfunctionAug 14, 2024Particulates; Particulates

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A EMPTY PCA VIAL WITH INJECTOR WHERE THE CUSTOMER STATED THAT THEY ARE FINDING NUMEROUS VIALS WITH PARTICLES IN PACKAGING AND INSIDE THE VIALS. THE PARTICULATES FOUND IN THE EMPTY UNITS PRIOR TO PRODUCTION AS WELL AS IN POST-PRODUCTION DURING VISUAL INSPECTION. THEY CONSIDER THE TESTING COMPLETED BY CUSTOMER (OURPHARMA LLC) WITH FINDINGS OF CARDBOARD, ORGANIC MATERIALS AND DIFFERENT COLORED FIBERS TO BE VALID SINCE THESE WERE FOUND DURING VISUAL TESTING ON THEIR SITE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE REACTION OR NEED FOR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982451 ↗
• MalfunctionAug 9, 2024Particulates; Particulates

  THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED AN EMPTY PCA VIAL WITH INJECTOR WHERE THE CUSTOMER REPORTED THAT THEY WERE FINDING NUMEROUS VIALS WITH PARTICLES IN PACKAGING AND INSIDE THE VIALS. THE PARTICULATES FOUND IN THE EMPTY UNITS PRIOR TO PRODUCTION AS WELL AS IN POST PRODUCTION DURING VISUAL INSPECTION. THE CUSTOMER IS CONSIDERING THE TESTING COMPLETED BY CUSTOMER (OURPHARMA LLC) WITH FINDINGS OF CARDBOARD, ORGANIC MATERIALS AND DIFFERENT COLORED FIBERS TO BE VALID SINCE THESE WERE FOUND DURING VISUAL TESTING ON THEIR SITE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE REACTION OR NEED FOR MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19954762 ↗
• MalfunctionJun 27, 2024Particulates; Contamination /Decontamination Problem; Particulates; Contamination /Decontamination Problem

  THE EVENT ON AN UNSPECIFIED DATE INVOLVED UNSPECIFIED PCA VIALS THAT HAD FOREIGN MATTER INSIDE. IT WAS REPORTED THAT THE CUSTOMER WAS FINDING NUMEROUS VIALS WITH PARTICLES IN THE PACKAGING AND IN THE VIALS THEMSELVES. THEY HAD IN THE RECENT PAST HAD COMPLETE BATCHES REJECTED DUE TO THE PARTICULATES FOUND WHILE VISUALLY INSPECTED. THE CUSTOMER DID SENT TO A THIRD-PARTY LAB FOR TESTING WITH RESULTS BEING CARDBOARD, ORGANIC MATERIALS, AND DIFFERENT COLORED FIBERS. THERE WAS NO HARM REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630368 ↗
• MalfunctionJun 27, 2024Particulates; Contamination /Decontamination Problem; Particulates; Contamination /Decontamination Problem

  THE EVENT INVOLVED AN UNSPECIFIED PCA VIAL. THE CUSTOMER REPORTED THAT THEY FOUND NUMEROUS VIALS WITH PARTICLES IN THE PACKAGING AND IN THE VIALS THEMSELVES THAT WERE REJECTED AT INCOMING INSPECTION DUE TO THE PARTICULATES FOUND. THE CUSTOMER DID SENT TO A THIRD-PARTY LAB FOR TESTING WITH RESULTS BEING CARDBOARD, ORGANIC MATERIALS, AND DIFFERENT COLORED FIBERS. THERE WAS NO HARM REPORTED AS A CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19629628 ↗
• MalfunctionAug 22, 2018Contamination /Decontamination Problem

  PCA EMPTY VIAL AND PCA VIAL CAP CONTAINED VISIBLE PARTICULATE - A COMMON PROBLEM WE HAVE NOTED IN USING THE PRODUCT FOR MORE THAN 6 MONTHS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7809459 ↗