MAUDE Adverse Event Report: COVIDIEN CONTAINER SHARPS 5QT RED; CONTAINER, SHARPS

Model Number	8507SA
Medical Device Problem Code	Break (1069)
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 the sharps containers arrived with busted corners and the lids had pieces breaking off of them.
Additional Manufacturer Narrative
A review of the device history record (dhr) was completed and there were no nonconforming events documented.All dhr¿s are reviewed for accuracy prior to product release.No samples were submitted with the complaint however, 7 photographs were provided and reviewed which show what appears to be a stack of containers with breakage in the corner rim of the top 3 containers and what appears to be 1 lid cracked in the lid assembly.The potential root cause for the reported issue is that the containers and/or lids cracked during shipping and handling due to external stress/forces after manufacture.Based on the existing controls, and the complaint history review, additional correction or containment activities are not warranted at this time.Product is routinely examined to ensure it meets all acceptance quality limits.All lots are statistically sampled and inspected for deficiencies prior to release.A lot cannot be released unless it meets all acceptance requirements.This will be used for tracking and trending purposes.

• Brand Name: CONTAINER SHARPS 5QT RED
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 9768981
• Report Number: 1424643-2020-00565
• Device Sequence Number: 11365607
• Product Code: MMK
• UDI-Device Identifier: 10884521023284
• UDI-Public: 10884521023284
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 04/15/2020

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: 8507SA
• Device Catalogue Number: 8507SA
• Device Lot Number: 19M15363
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/17/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/15/2020
• Patient Sequence Number: 1