MAUDE Adverse Event Report: COVIDIEN 3GA ALWAYS OPEN INROOM -T RED; CONTAINER, SHARPS

Model Number	85221R
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 case of red containers 3 out of 10 safety lids are cracked and not safe to use.No damage to the outside of case.
Additional Manufacturer Narrative
A review of the device history record was unable to be performed as no lot number was supplied.A lot will not be released unless all acceptance criteria inspections per established sampling levels are within acceptable limits.Samples were supplied for analysis.Cracked lids were observed on all three samples.Cracks were in the same location on each sample with the extent of damage varying.The samples were not in the original packaging.The method of a root cause analysis implemented in this investigation was to conduct a six m assessment that evaluated potential causes.A specific root cause could not be determined, however there are two potential causes; (1) human error with the associate incorrectly packaging the case or (2) a supply chain failure with the customer who distributed the product to their end customer repackaging the case in their own configuration without meeting the packaging configuration requirements.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.

• Brand Name: 3GA ALWAYS OPEN INROOM -T RED
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 9475660
• Report Number: 1424643-2019-00559
• Device Sequence Number: 2790292
• Product Code: MMK
• UDI-Device Identifier: 10884521023369
• UDI-Public: 10884521023369
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: 85221R
• Device Catalogue Number: 85221R
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 02/18/2020
• Patient Sequence Number: 1