MAUDE Adverse Event Report: COVIDIEN SHARPSAFETY; CONTAINER, SHARPS

Model Number 8507SA

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states that a needle went through the plastic (sharps container) and injured the physician.The needle stick occurred on the physician's left hand.

Manufacturer Narrative

Submission date: 08/09/2018.A review of the device history records (dhr) for reported lot number 17k15663 indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.The actual device was not returned for evaluation.Without the device or a representative sample being provided, a more comprehensive investigation could not be performed.The reported issue could not be replicated.However, one (1) digital image (photograph) was provided from the customer.Upon review of the photograph, the following observation was noted: the needle was protruding through container in the middle part of the container¿s short side.The fill level of the container could not be determined.Potential root causes for the event may include: improper handling/carrying of a filled sharps container below recommended fill line by user.The instructions for use (ifu) carrying/lifting instructions indicate the user should never hold or carry used container below recommended fill line and to utilize additional caution with containers that do not have handles.It also warns the user not to hold or carry container close to the body.Labeling cautions that forcing could result in puncture and that excessive force used to drop sharps in the container may result in container puncture.Based on the information provided, this appears to be an isolated event.The reported customer complaint is confirmed.A root cause could not be determined.The most likely probable cause is the carrying/lifting instructions were not followed by user.No corrective or preventive action is planned at this time.This complaint will be used for 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: 7390248
• MDR Text Key: 104106839
• Report Number: 1424643-2018-00004
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 20884521023281
• UDI-Public: 20884521023281
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8507SA
• Device Catalogue Number: 8507SA
• Device Lot Number: 17K15663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/14/2018
• Date Device Manufactured: 12/04/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention