inforMED

PROTOCOL PARASITOLOGY SYSTEM

Received Aug 9, 2006 · Event occurred Aug 4, 2006

Report 748604 · MDR key 748604

Device

Generic name

Specimen Collection Kit For Stool Ova Parasites

Manufacturer

Fisher Diagnostics

Model number

*

Catalog number

*

Lot number

120705-00

Product problems

  • Labelling, Instructions for Use or Training Problem
  • Inadequate Service
  • Use of Device Problem

Patient

26 YR

  • Vomiting
  • Chemical Exposure
  • Treatment with medication(s)
  • Hospitalization required

Narrative

Description of Event or Problem

HISPANIC PATIENT ADMITTED FOR DIARRHEA AND HYPOKALEMIA HAD ORDER TO OBTAIN STOOL FOR OVA AND PARASITES. THE TEST KIT THAT CONTAINS TWO 15ML VIALS OF PRESERVATIVE CHEMICALS WAS PLACED IN THE PATIENT'S BATHROOM AND INSTRUCTIONS GIVEN VERBALLY. THE NEXT DAY, THE PATIENT WAS SEEN EXITING THE BATHROOM CARRYING ONE OF THE VIALS. THE STAFF MEMBER WHO SAW HIM THOUGHT HE'D OBTAINED A SPECIMEN AND NOTIFIED HIS NURSE. SHE FOUND THE PATIENT VOMITING. WHEN ASKED THROUGH AN INTERPRETER HE STATED "HE WANTED TO GO HOME BECAUSE THE MEDICINE WAS MAKING HIM SICKER." THE PATIENT HAD INGESTED THE CONTENTS OF BOTH VIALS (NO SPECIMEN). THE OUTSIDE LABEL INDICATES THAT ONE VIAL CONTAINS POLYVINYL CHLORIDE AND MERCURIC CHLORIDE (LV-PVA FIXATIVE) AND THE SECOND VIAL CONTAINS 10% BUFFERED NEUTRAL FORMALIN (FORMALDEHYDE). THE LABEL ON THE OUTSIDE OF THE PLASTIC BAG INDICATES IN SMALL PRINT "POISON. DO NOT DRINK. IF INGESTED, CONTACT PHYSICIAN IMMEDIATELY." THE LABEL ON ONE VIAL STATES "CONTAINS FORMALDEHYDE 4%" "POTENTIAL CANCER HAZARD" "RESPIRATORY SENSITIZER. HARMFUL/DO NOT DRINK. IF INGESTED CONTACT PHYSICIAN IMMEDIATELY." THE SECOND PVA VIAL STATES "CAUTION FLAMMABLE" "CONTAINS REAGENT ALCOHOL AND MERCURIC CHLORIDE. "HARMFUL / DO NOT DRINK. IF INGESTED CONTACT PHYSICIAN IMMEDIATELY." THERE ARE TWO ICONS FOR POISON, SKULL AND CROSSBONES AND A "YUCKY FACE" ON BOTH VIALS. BOTH OF THESE ICONS ARE SMALL, APPROX. THE SIZE OF A PENCIL ERASER. ALL OF THE LABELS ON BOTH VIALS WERE COVERED BY THE PATIENT ID LABEL. NONE OF THE DOCUMENTATION IS IN SPANISH. THERE IS AN INSERT THAT GIVES BRIEF INFORMATION IN MULTIPLE LANGUAGES FOR INGESTION MANAGEMENT. THE INSTRUCTIONS INCLUDE TO INDUCE VOMITING. (THE MSDS FOR THIS PRODUCT INDICATED TO NOT INDUCE VOMITING.) THERE IS NO INFORMATION ON THIS FLYER TO CALL POISON CONTROL. THE CAPS ARE NOT CHILDPROOF. THESE KITS ARE ALSO SENT HOME FOR SPECIMEN COLLECTION. THERE ARE NO OTHER INSTRUCTIONS IN EITHER ENGLISH OR ANY OTHER LANGUAGE AS TO HOW TO USE THE KIT. THEREFORE, THE PATIENT MUST BE GIVEN VERBAL INSTRUCTION. THE LABEL INDICATES TO CALL FOR "TECHNICAL ASSISTANCE" BUT WHEN WE DID, THE COMPANY HAD NO KNOWLEDGE ABOUT THE CHEMICALS AS THEY ARE ONLY A DISTRIBUTOR. IT TOOK THEM AN HOUR TO GET US IN CONTACT WITH THE ACTUAL MANUFACTURER FOR DETERMINATION OF THE AMOUNT OF MERCURY ACTUALLY INGESTED. THIS IS THE MOST DANGEROUS CHEMICAL IN THE KIT AS IT IS A HEAVY METAL. THE PATIENT INGESTED 0.6 MG OF MERCURY. IT IS CONSIDERED TO BE A POTENTIALLY LETHAL DOSE IF GREATER THAN 1 MG IS INGESTED. THE PATIENT HAS NOW BEEN RECEIVING A CHELATING DRUG THAT IS VERY DIFFICULT TO FIND TO COUNTERACT THE HEAVY METAL RISKS IN THE LONG TERM. POISON CONTROL WAS CALLED IMMEDIATELY AFTER THE SITUATION WAS IDENTIFIED. THE PATIENT WAS ALREADY VOMITING. TO DATE, HE HAS HAD NO SEQUELAE FROM THIS EVENT OTHER THAN THE ADDITIONAL HOSPITAL STAY AND NEED FOR THE CHELATING DRUG INJECTIONS.