MAUDE Adverse Event Report: COVIDIEN SHARPS CONTAINER 18GAL SLIDE-; CONTAINER, SHARPS

Model Number 8998SPG2

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Chemical Exposure (2570)

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested but to date has not yet been provided.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

The customer states the round lid that is supposed to be pushed down to lock, flipped when pushed down and the staff members hands went inside the bin ripping their gloves, touching the chemo waste inside, and their hand got wet with the chemo drugs inside the bin.

Manufacturer Narrative

A review of the device history record (dhr) for lot no.18d16163 indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.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.For sterilized products, the dhr and the sterilization documents undergo further review prior to release.Two (2) images were received for evaluation.Analysis of the images observed the yellow lid is shown turned 90 degrees and into the waste, the entire top is out of the sliding tracks and there are no apparent molding defects from images.The method of root cause analysis that was implemented in this investigation was to conduct a six m assessment.The assessment evaluated potential causes and identified the following: user did not follow ifu instruction on lid for correct positioning before locking.The potential root cause has been determined to be user error and not following the usage instructions.The reported customer complaint was confirmed.The root cause could not be determined.The potential root cause has been determined to be user error and not following the usage instructions.This complaint will be used for tracking and trending purposes.

• Brand Name: SHARPS CONTAINER 18GAL SLIDE-
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 8218555
• MDR Text Key: 132210388
• Report Number: 1424643-2019-00523
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/13/2019

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
• Device Operator: No Information
• Device Model Number: 8998SPG2
• Device Catalogue Number: 8998SPG2
• Device Lot Number: 18D16163
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 01/04/2019
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1