MAUDE Adverse Event Report: CARDINAL HEALTH 1 QT TRANSPORTABLE CONT; CONTAINER, SHARPS

Model Number 8303SA

Device Problem Material Puncture/Hole (1504)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 06/22/2021

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 needle poked through the side of the container at some point eventually causing someone to receive a finger stick.Additional information was received stating that the needle stick was from a contaminated needle.

Manufacturer Narrative

The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue described by the customer.There were no samples submitted with this complaint however a photograph provided by the customer shows a needle protruding from the side of the container at or below the full line.Based on the information available and the investigation findings, additional actions are deemed unnecessary at this time.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.The potential root cause for a needle puncturing at or just below the ¿full¿ line could occur if the container was full at the time of the puncture.According to the instructions for use (ifu) the user is directed to ¿drop¿ the syringe in and forcing, compressing or overfilling could cause a puncture which may result in injury.All available evidence suggest that the user may have forced the syringe into the container instead of dropping in the container and that the container was likely at the full limit.

• Brand Name: 1 QT TRANSPORTABLE CONT
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): CARDINAL HEALTH; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 12091959
• MDR Text Key: 259130693
• Report Number: 1424643-2021-00607
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 10884521023666
• UDI-Public: 10884521023666
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8303SA
• Device Catalogue Number: 8303SA
• Device Lot Number: 19G18163
• Date Manufacturer Received: 06/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other