Reporting Tip: Threw Away the Packaging?
MedSun: Newsletter #18, November 2007
What should you do when you are preparing a [MedSun] Medical Device Report about a problem with a single-use product or device but discover that the packaging of the item has been discarded and can’t be retrieved?
If the original packaging — which includes crucial information to accurately identify the product or device — is not available, please consider the following to obtain the information required to analyze your report.
1. Locate a stock of identical products on the unit or in a nearby supply room.
2. Photocopy the packaging of a like-device to produce an image with the information needed to complete the report —with the possible exception of the actual lot number of the device involved.
3. Attach image to 3500A form. Please make the distinction in your report that it is “sample packaging from like-product.” This copy of the product packaging will be scanned with the report to make exact identification of the product or device more efficient.