inforMED
MalfunctionIFP

PRE-FILLED FORMALIN

Received Sep 13, 2024 · Event occurred Nov 3, 2023

Report 20211219 · MDR key 20211219

Device

Generic name

Formalin, Neutral Buffered

Model number

PFNBF-1-25G

Catalog number

PFNBF-1-25G

Lot number

34957

Patient

122 YR · Unknown

  • Eye Injury
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
  • Eye Injury
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

Narrative

Description of Event or Problem

FAULTY PACKAGING FOR THE PRE-FILLED FORMALIN. WE RECEIVED THE REPLACEMENT ITEM FOR THE ONE THAT WAS DAMAGED ON MONDAY, BUT UNFORTUNATELY, THE REPLACEMENT IS ALSO DAMAGED. THE FEDEX DRIVER WHO DELIVERED THE ITEM WAS NOT AWARE THAT IT WAS LEAKING, AND AS A RESULT, THE PRODUCT SPILLED ALL OVER THE TRUCK. THIS CAUSED THE DRIVER TO EXPERIENCE WATERY EYES AND AN UNCOMFORTABLE IRRITATION IN HER NOSE. THE DRIVER DECIDED TO QUIT HER JOB ON THE SAME DAY, AS THE PACKAGING OF THE PRODUCT IS DEFECTIVE. WE KINDLY REQUEST YOU TO PASS ON THIS INFORMATION TO THE RELEVANT DEPARTMENT, SO THEY CAN TAKE NECESSARY ACTIONS TO CHANGE HOW PRODUCT NUMBER [PRODUCT # REDACTED] IS LABELED. WE APPRECIATE YOUR EFFORTS. HOWEVER, PLEASE DO NOT SEND US A REPLACEMENT FOR THIS PRODUCT. WE WILL PURCHASE IT FROM AN ALTERNATE SOURCE. MANUFACTURER RESPONSE FOR PRE-FILLED FORMALIN, PRE-FILLED FORMALIN (PER SITE REPORTER), NO RESPONSE AS OF YET