APTIMA SPECIMEN TRANSFER KIT
Received Apr 28, 2016 · Event occurred Mar 30, 2016
Report 2024800-2016-00016 · MDR key 5616504
Device
Generic name
In-vitro Diagnostic Assay
Manufacturer
Hologic, Inc.Model number
301154Catalog number
301154
Product problems
- Nonstandard Device
- Use of Device Problem
Patient
Not reported
- Sore Throat
- Sore Throat
Narrative
Description of Event or Problem
A NURSE INDICATED SHE MAY HAVE INGESTED MEDIA FROM THE APTIMA LIQUID PAP TRANSFER TUBE (PN: (B)(4)). THE NURSE HAD POURED THE MEDIA FROM THE TUBE AND SUSPECTS THAT SOME MAY HAVE SPLASHED UP ONTO HER HAND. AFTER, THE NURSE OPENED HER COFFEE MUG TO DRINK. LATER, THE NURSE INDICATED SHE DEVELOPED A SORE THROAT. SHE WAS UNSURE IF ANY OF THE MEDIA FROM THE APTIMA LIQUID PAP TRANSFER TUBE MAY HAVE GOTTEN ON HER HAND AND INTO HER COFFEE MUG. THE APTIMA LIQUID PAP TRANSFER TUBE DID NOT CONTAIN PATIENT SAMPLE. ACCORDING TO THE SAFETY DATA SHEET FOR THIS PRODUCT, THE MEDIA IS NOT CONSIDERED HAZARDOUS.
Remedial action
- Recall