MAUDE Adverse Event Report: CARDINAL HEALTH SHARPS CONTAINER 12GAL RED; CONTAINER, SHARPS

Model Number	8932PG2
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
Customer reports: a contaminated needle stick injury occurred when trying to insert the needle into the sharps container.The new sharps containers do not open smoothly or all the way making it difficult to discard of a needle.The lpn received standard follow up testing and requires no additional follow up testing.

• Brand Name: SHARPS CONTAINER 12GAL RED
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): CARDINAL HEALTH; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 11965177
• Report Number: 1424643-2021-00606
• Device Sequence Number: 11865660
• Product Code: MMK
• UDI-Device Identifier: 40884521022417
• UDI-Public: 40884521022417
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8932PG2
• Device Catalogue Number: 8932PG2
• Device Lot Number: 20M04563
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 06/09/2021
• Patient Sequence Number: 1