MAUDE Adverse Event Report: COVIDIEN SHARPSAFETY; CONTAINER, SHARPS

Model Number 8982

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

Initial submit date: (b)(6) 2017 an investigation is currently underway; once completed, the results will be forwarded.

Event Description

The customer reports a needle was poking through the sharps container when the needle pricked a nurse.

Manufacturer Narrative

Submit date: 10/17/2017.Sections has been updated from 10/12/2017 to reflect that an adverse event had occurred.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports a needle was poking through the sharps container when the needle pricked a nurse.

Manufacturer Narrative

Unused samples were received that consisted of 11 containers and 12 lids which met acceptance criteria.The complaint is for a contaminated needle stick and because the actual sample was not received, a product analysis on the actual sample cannot be performed.The reported condition was not observed on the returned samples.The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The potential root cause may be customer misuse.There was no information provided for where the needle was punctured through the container or which part of the body the nurse received the needle stick.The instructions for use (ifu) states ¿use additional caution with containers that do not have handles.¿ the most probable root cause is failure to follow the ifu for carrying/lifting the sharps disposal.This issue has been determined to be an isolated event.Based on the existing controls, the internal reject and the complaint history review, no formal investigation is required at this time.If additional information is obtained, or the actual sample is returned, this file will be re-opened for further investigation.This complaint will also be used for 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 ; 5082618000
• MDR Report Key: 6946555
• MDR Text Key: 89829501
• Report Number: 1424643-2017-05031
• 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,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8982
• Device Catalogue Number: 8982
• Device Lot Number: 17E33063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other