MAUDE Adverse Event Report: CAPITOL VIAL INC. THERMO SCIENTIFIC LABCORP HD COURIER KITS 50/CS; SPECIMEN TRANSPORT AND STORAGE CONTAINER.

Model Number 90001

Device Problems Off-Label Use (1494); Inadequate or Insufficient Training (1643); Use of Device Problem (1670)

Patient Problem No Information (3190)

Event Date 08/10/2016

Event Type  Injury  

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.

Event Description

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.

• Brand Name: THERMO SCIENTIFIC LABCORP HD COURIER KITS 50/CS
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER.
• Manufacturer (Section D): CAPITOL VIAL INC.; auburn AL
• Manufacturer Contact: christine ehmann ; 75 panorama creek drive; rochester, NY 14625 ; 5858997234
• MDR Report Key: 6119129
• MDR Text Key: 60624073
• Report Number: 1062700-2016-00001
• Device Sequence Number: 1
• Product Code: NNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 90001
• Device Catalogue Number: 22-038-820
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other