MAUDE Adverse Event Report: COVIDIEN SHARPSAFETY; CONTAINER, SHARPS

Model Number 8507SA

Device Problem Fitting Problem (2183)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports the lids were not fitting correctly.The customer states the tops of the sharps container was missing the sliding part of the lid that locks and snaps into place.

Manufacturer Narrative

The reported condition cannot be observed as no photo or no physical sample was submitted for evaluation.A device history (dhr) review cannot be performed as lot no.Information is not available.The root cause cannot be determined without a sample or photo for product analysis.Also the dhr review cannot be performed as the lot number is unknown.The potential cause may be user error to follow guideline for lid fit per instruction for use (ifu).Also as per the complaint quantity 6 eaches shows the finished good case 20 eaches/case was broken down outside of cardinal health which may cause not using the correct lid and container together.Based on the existing controls, the internal reject and the complaint history review, no formal investigation is required at this time.This will be used for tracking and trending purposes.This issue has been determined to be an event with no user harm or injury.Based on the above information and the minimal information present in the complaint and lack of sample/photo the reported condition was not observed.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: 6956789
• MDR Text Key: 89996276
• Report Number: 1424643-2017-05032
• 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: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8507SA
• Device Catalogue Number: 8507SA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1