MAUDE Adverse Event Report: COVIDIEN SHARPSAFETY; CONTAINER, SHARPS

Model Number 8938

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 10/09/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.If information is provided in the future, a supplemental report will be issued.

Event Description

Customer reports that the lid was not able to close because the product was distorted prior to its use.No patient involved.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a thorough follow up investigation to include functional and visual evaluations to confirm the reported issue and root cause analysis.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.A potential root cause may be that the product was damaged during shipping and handling due to external stress/forces which may cause the lid to not attach/stay attached.Based on the existing controls, the internal reject and the complaint history review, a formal investigation is not deemed necessary at this time.If additional information is obtained, or the sample is returned, this file will be re-opened for further investigation.This complaint will be used for qa tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHARPSAFETY
• Type of Device: CONTAINER, SHARPS
• 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: 6969823
• MDR Text Key: 90065229
• Report Number: 1424643-2017-05033
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8938
• Device Catalogue Number: 8938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1