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

Model Number 8932PG2

Device Problem Fail-Safe Problem (2936)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/20/2021

Event Type  Injury  

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 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
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): CARDINAL HEALTH; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer (Section G): CARDINAL HEALTH; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11965177
• MDR Text Key: 255069521
• Report Number: 1424643-2021-00606
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 40884521022417
• UDI-Public: 40884521022417
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: 8932PG2
• Device Catalogue Number: 8932PG2
• Device Lot Number: 20M04563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 06/09/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1