BOX OF SPECIMEN COLLECTION KITS, MULTITEST SWAB
Received Jan 9, 2017 · Event occurred Dec 12, 2016
Report 2024800-2017-00001 · MDR key 6234824
Device
Product problems
- Improper or Incorrect Procedure or Method
- Chemical Spillage
- Human Factors Issue
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
(B)(6) WAS CONTACTED BY A DOCTORS SURGERY AT THE (B)(6). THE DOCTORS SURGERY REPORTED THEIR PATIENT TOLD THEM THAT THE TUBE CONTAINING THE TRANSPORT MEDIA HAD BEEN LEFT OPEN BY THE PATIENT AND IN THE SAME ROOM AS HER CHILD. WHEN SHE CAME BACK IN THE ROOM THE TUBE WAS KNOCKED OVER AND THE FLUID WAS SPILLED ON THE SIDE NEXT TO THE CONTAINER. THE TUBE ONLY CONTAINED TRANSPORT MEDIA, AND DID NOT CONTAIN SAMPLE AT THAT TIME. THE PATIENT THOUGHT THAT HER CHILD HAD KNOCKED OVER THE CONTAINER AND WAS UNSURE IF THE CHILD SWALLOWED ANY LIQUID. MEDICAL ATTENTION PROVIDED. NO DETAILS REPORTED. NO FOLLOW UP TREATMENT INFORMATION WAS PROVIDED. HOLOGIC PROVIDED SDS TO REPORTER, AS REQUESTED.