MAUDE Adverse Event Report: COVIDIEN 3 GA RENEWABLES DIALYSIS; CONTAINER, SHARPS

Model Number	8964
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional 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.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that there were cracks on the lid and body of the container.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot number could not be provided by the customer.A sample was not provided for evaluation therefore the reported conditions stated by the customer could not be determined as neither samples nor photos were not available for evaluation.The potential root cause for a cracked container and lid could occur during shipping and handling due to external stress/forces post manufacturing or the container and lid may have cracked due to a sharp impact during use.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 cracks and other anomaly¿s prior to release.A lot cannot be released unless it meets all acceptance requirements.

• Brand Name: 3 GA RENEWABLES DIALYSIS
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 9769610
• Report Number: 1424643-2020-00566
• Device Sequence Number: 2488180
• Product Code: MMK
• UDI-Device Identifier: 40884521018250
• UDI-Public: 40884521018250
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/20/2020

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: 8964
• Device Catalogue Number: 8964
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/20/2020
• Patient Sequence Number: 1