MAUDE Adverse Event Report: COVIDIEN 1 QT PHLEBOTOMY CONT; CONTAINER, SHARPS

Model Number 8900SA

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/22/2018

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.

Event Description

Per customer report: a needle went through the sharps container and stuck me when i went to place it in the biohazard waste.

Manufacturer Narrative

The lot number initially provided by the client was deemed invalid.Therefore, no lot number was provided.Lot number is unknown.A valid lot number was not provided.The number provided, cl63r4422a, represents a label for (b)(4), pss select 1 qt phlebotomy sharpsafety sharps container.Therefore, a review of the device history record (dhr) was unable to be performed.However, all dhrs are reviewed for accuracy prior to product release.In-process procedures are in place to prevent nonconforming product in the manufacturing process.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.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.The complaint file contains insufficient information to determine a specific root cause.The reported customer complaint is unable to be confirmed.A root cause could not be determined.Probable root cause could not be determined as the available evidence is too limited to draw a reasonable conclusion.A formal capa investigation is currently in progress.This complaint will be utilized for tracking and trending purposes.

• Brand Name: 1 QT PHLEBOTOMY CONT
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 7961955
• MDR Text Key: 123565340
• Report Number: 1424643-2018-00508
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 8900SA
• Device Catalogue Number: 8900SA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/16/2018
• Initial Date FDA Received: 10/12/2018
• Supplement Dates Manufacturer Received: 08/16/2018
• Supplement Dates FDA Received: 12/04/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other