MAUDE Adverse Event Report: COVIDIEN 18 GA RENEWABLES HINGE LID; CONTAINER, SHARPS

Model Number	8991
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional 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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the product was cracked.
Additional Manufacturer Narrative
Additional information: 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 dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A digital photograph of the product was available for analysis.The picture shows a crack along the side of the container near the top.There is not enough information available to determine a root cause; however, it is possible that during shipping/distribution the product was damaged.No corrective and preventative actions are deemed necessary at this time.The manufacturing site will continue monitoring the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: 18 GA RENEWABLES HINGE LID
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 9329391
• Report Number: 1424643-2019-00552
• Device Sequence Number: 10859711
• Product Code: MMK
• UDI-Device Identifier: 30884521022267
• UDI-Public: 30884521022267
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2020

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
• Operator of Device: No Information
• Device Model Number: 8991
• Device Catalogue Number: 8991
• Device Lot Number: 19H22863
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 01/20/2020
• Patient Sequence Number: 1