MAUDE Adverse Event Report: CARDINAL HEALTH 8 GA PG2 YELLOW HING LID; CONTAINER, SHARPS

Model Number 8985PG2Y

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem Pain (1994)

Event Date 10/05/2021

Event Type  malfunction  

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

The customer reported that sharp containers are extremely difficult to seal.There have been numerous incidents where nursing staff was unable to click all the latches due to their physical ability to provide enough strength to do so.The lids just won't close.The nurses are experiencing physical pain in arms and hands.

Manufacturer Narrative

The device history record (dhr) review concluded no abnormal process conditions were present during the manufacturing of this product that would lead to the reported condition.A sample was not provided for analysis therefore the method of a 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.It is possible that the reported condition occurred during the lid assembly process or as a result of transportation of the product.Currently here is no additional evidence to make a definitive root cause.A formal corrective/preventative action (capa) was initiated to investigation complaint trend for the lid fit in this product category.

Manufacturer Narrative

Additional information h2, h3, h6.Investigation conclusion the customer reported that sharps containers are extremely difficult to seal.There have been numerous incidents where nursing staff was unable to click all the latches due to our physical ability to provide enough strength to do so.The lids just won't close.The nurses are experiencing physical pain in arms and hands.The device history record (dhr) review concluded no abnormal process conditions were present during the manufacturing of this product that would lead to the reported condition.The reported product was returned for evaluation.Dimentional testing performed, identified the gasket was slightly interferring with the max height gauge.Functional lid fit testing passed with no issues.An investigation was initiated and a cause-and-effect assessment was performed.A root cause could not be confirmed with available information.The following potential root causes were evaluated: 1.Human error - unlikely: instructions for use (ifu) are provided with this product.The ifu provides the following assembly instructions: ¿snap lid on container with inged lid open.Listen for snaps.Please check that the container has suffered no shipping damage before placing into use.¿ at this time there is no evidence that the end user didn¿t follow these instructions.2.Gasket height ¿ possible: if excessive gasket material is placed on the lid it may lead to difficulty closing the lid.Gasket measurements are taken during manufacturing to ensure the gasket material is within specification and does not interfere with closure.All inprocess inspections passed.Additionally, lid fit and leak tests are performed and no issues were identified during manufacturing.The gasket height on a sample provided by the customer was measured at it was observed that the gasket was slightly above the height specification.3.Injection molding ¿ unlikely: defects in the molded product may contribute to issues with lid fit; however, lid fit and leak tests are performed during production and no issues were identified during manufacturing.Therefore, at this time it is unlikely that injection molding contributed to the defect.This complaint will be used for monitoring and trending purposes.

• Brand Name: 8 GA PG2 YELLOW HING LID
• 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: 12721343
• MDR Text Key: 279893801
• Report Number: 1424643-2021-00621
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 20884521154244
• UDI-Public: 20884521154244
• 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: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8985PG2Y
• Device Catalogue Number: 8985PG2Y
• Device Lot Number: 21F11063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2021
• 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