MAUDE Adverse Event Report: COVIDIEN Kendall

Model Number 8612RC

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 05/01/2017.An investigation is currently under way; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states that the tops/lids will not secure.

Manufacturer Narrative

The reported condition cannot be observed as no photo or physical sample available for sample evaluation.A device history record reviewed for 8612rc for lot number 173392 indicates that there was no internal reject found during production.The most probable root cause for the reported condition is that the tool used to manufacture the lid has a larger rim height than the too used for the container which causes the lid locks to be difficult to secure around the rim.A formal corrective and preventative action (capa) will address the container tool deficiency.If information is provided in the future, a supplemental report will be issued.

• Brand Name: Kendall
• Manufacturer (Section D): COVIDIEN; 815 tek dr; crystal lake IL 60014 8172
• Manufacturer (Section G): COVIDIEN; 815 tek dr; crystal lake IL 60014 8172
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6534799
• MDR Text Key: 74304074
• Report Number: 1424643-2017-05006
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8612RC
• Device Catalogue Number: 8612RC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1