MAUDE Adverse Event Report: CARDINAL HEALTH 5QT.CNT.W/TRNS YELLOW CONT. 20; CONTAINER, SHARPS

Model Number 8506Y

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reported that this permanent substitute is very difficult to use due to the small opening and the counter-balanced lid.The staff spends excess time ensuring the sharps descend into the container.Additional information received from the customer stated that they do not like the design of the counter-balanced lid.The lid is slow to accept items.They stock these containers so they have many.When syringes with labels attached from the omnicell are placed in the sharps containers, the labels end up sticking to the sides of the opening preventing other items from dropping in.When depositing large items, like cvc sharps and needle/syringes used to perform blocks, the items get stuck in the narrow opening.Staff has to shake and knock the containers to get items to fall in.They did not have any of these issues with the open lid design.

Manufacturer Narrative

The device history record (dhr) review was not possible as a lot number was not available for review; however, a lot will not be released without meeting all criteria.At the time of this investigation a sample was not available for analysis e description indicates that the customer is using an inappropriate sized container for their needs.The instructions for use for this device provides a warning to ¿use the proper size container for the items and volume being disposed¿.A formal corrective/preventative action (capa) is deemed not necessary based on reported condition¿s risk to patient/user and trending.The issue will be monitored through routine complaint trend analysis and reviewed by a capa review board (crb) to determine if a capa becomes necessary.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.

Manufacturer Narrative

See section d4 for lot number information.The lot # 21c09063 was received with the returned sample.The reported lot was released on 5/20/2021 through 5/30/2021.The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One unused sample was returned for the evaluation.Visual and function testing has been performed.Upon analysis, it was determined that container and lid were assembled per the instructions for use (ifu).No issues were observed in the functionality of the lid.The product meets all requirements.The method of root cause analysis that was implemented in this investigation was to conduct a cause-and-effect assessment.The assessment evaluated potential causes: human, material, method, measurement, machine, and environment.The significant root cause of the reported issue could be due to user error.The complaint description indicates that the customer is using an inappropriate sized container for their needs.The instructions for use (ifu) for this device provides a warning to ¿use the proper size container for the items and volume being disposed¿.The customer also indicated that ¿staff has to shake and knock the containers to get items to fall in¿.The instructions for use for this device provides a warning to the user that: ¿do not strike, tap, shake or manipulate container for any reason i.E., to settle contents¿.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 5QT.CNT.W/TRNS YELLOW CONT. 20
• 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 ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12635854
• MDR Text Key: 276651778
• Report Number: 1424643-2021-00620
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 10884521023260
• UDI-Public: 10884521023260
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8506Y
• Device Catalogue Number: 8506Y
• Device Lot Number: 21C09063
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 09/23/2021; 09/23/2021
• Supplement Dates FDA Received: 10/25/2021; 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1