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

Model Number 8964

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2020

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.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that there were cracks on the lid and body of the container.

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
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 9769610
• MDR Text Key: 181539940
• Report Number: 1424643-2020-00566
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 40884521018250
• UDI-Public: 40884521018250
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• Device Model Number: 8964
• Device Catalogue Number: 8964
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 04/20/2020
• Patient Sequence Number: 1