McKesson 16-S20CRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10612479206912), received between Apr 25, 2022 and Jun 24, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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.

• MalfunctionJun 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A BLACK HAIR WAS DISCOVERED INSIDE A STERILE SYRINGE, THEY BELIEVE THAT THE HAIR COULD NOT HAVE BEEN DRAWN UP THROUGH THE NEEDLE, THE HAIR WAS LIKELY PRESENT IN THE SYRINGE PRIOR TO ITS USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19592081 ↗
• MalfunctionMay 17, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE CUSTOMER THAT A BLACK HAIR WAS DISCOVERED INSIDE A STERILE SYRINGE. THE CUSTOMER STATED THAT THEY DID NOT BELIEVE THE HAIR COULD HAVE BEEN DRAWN UP THROUGH THE NEEDLE. IT WAS INDICATED THAT THE HAIR WAS LIKELY PRESENT IN THE SYRINGE PRIOR TO ITS USE. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340789 ↗
• MalfunctionApr 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THERE'S A FOREIGN OBJECT ON THE BARREL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102929 ↗
• MalfunctionApr 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT CRACKED BARREL, DRUG LEAKAGE DURING DRUG DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102804 ↗
• MalfunctionApr 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT CRACKED BARREL, DRUG LEAKAGE DURING DRUG DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102803 ↗
• MalfunctionDec 23, 2022Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EMPLOYEE WAS SPRAYED IN THE EYES WITH A CHEMOTHERAPY DRUG,CARBOPLATIN CAUSING CHEMICAL ABRASIONS TO THE RIGHT EYE.THE 20ML SYRINGE CRACKED DURING INJECTION OF THE DRUG INTO A BAG.ANTIBIOTIC DROPS AND AN OPHTHALMOLOGIST FOLLOW UP WERE REQUIRED.

  Patient problems: Chemical Exposure; Eye Injury

  MAUDE report 16045722 ↗
• MalfunctionApr 25, 2022Fracture

  SYRINGE HAD A FRACTURE IN BARREL "AND" COULD NOT DRAW UP MEDICATION. SYRINGE HAD A LONG CRACK DOWN THE BARREL OF SYRINGE. TECHNICIAN HAD TO STOP COMPOUNDING A BIOLOGIC (TYSABRI), WHEN IT WAS EVIDENT SYSTEM HAS NOT SEALED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14207583 ↗