THERMO SCIENTIFIC LABCORP HD COURIER KITS 50/CS
Received Nov 21, 2016 · Event occurred Aug 10, 2016
Report 1062700-2016-00001 · MDR key 6119129
Device
Generic name
Specimen Transport And Storage Container.
Manufacturer
Capitol Vial Inc.Model number
90001Catalog number
22-038-820
Product problems
- Off-Label Use
- Inadequate or Insufficient Training
- Use of Device Problem
- Off-Label Use
- Inadequate or Insufficient Training
- Use of Device Problem
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
BASED ON THE INITIAL REPORT, SUBSEQUENT COMMUNICATION WITH THE REPORTER AND THE PRODUCT IDENTIFIED IN THE COMPLAINT, THE DEVICE WAS NOT USED AS INTENDED. THE INTENDED USE OF THE DEVICE IS FOR TRANSPORT AND STORAGE OF SPECIMENS, NOT COLLECTION OF SPECIMENS. THE DEVICE HAS NOT BEEN MADE AVAILABLE TO NALGE NUNC INTERNATIONAL OR CAPITOL VIAL AT THIS TIME. NALGE NUNC INTERNATIONAL IS SEEKING ADDITIONAL INFORMATION FROM THE REPORTER TO FURTHER THE INVESTIGATION.
Description of Event or Problem
DURING A PROCEDURE TO OBTAIN A URINE SAMPLE, A PATIENT ALLEGES SHE INCURRED AN INJURY REQUIRING STITCHES DUE TO THE SPECIMEN TRANSPORT AND STORAGE CONTAINER.