MAUDE Adverse Event Report: COVIDIEN SHARPSAFETY; CONTAINER, SHARPS

Model Number	8906
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 09/29/2017.An investigation is currently underway.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 or Problem Description
According to the reporter, on (b)(6) 2017, during use, the container did not close optimally.The system unscrewed the butterfly to barrel and did not work well.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Was evaluated for the reported condition of a malfunctioning lid.The reported condition cannot be observed from the photo provided by the customer.A device history record (dhr) review was performed and met acceptance criteria and no internal rejects were found during production.The probable root cause is that the end user did not follow temporary/final lock and carrying/lifting instructions per instruction for use (ifu).Also there is not much information available for product analysis.The information in the complaint is minimal to perform a thorough investigation to determine an exact root cause without a sample to evaluate.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 isolated event.As per complaint there was no patient involvement.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHARPSAFETY
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek dr; crystal lake IL 60014 8172
• MDR Report Key: 6905284
• Report Number: 1424643-2017-05025
• Device Sequence Number: 16264209
• Product Code: MMK
• UDI-Device Identifier: 30884521023431
• UDI-Public: 30884521023431
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017

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: Other
• Device Model Number: 8906
• Device Catalogue Number: 8906
• Device Lot Number: 00176515
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 12/07/2017
• Patient Sequence Number: 1