MAUDE Adverse Event Report: COVIDIEN 2 GAL CONTAINER, RED; CONTAINER, SHARPS

Model Number 31142222

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

Customer reports: the 1ml tuberculin syringe poked out of the sharps container after it was autoclaved.

Manufacturer Narrative

Update section d4: lot number added based on the customer provided photo.

Manufacturer Narrative

The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue described by the customer.There were no samples submitted with this complaint however a photograph provided by the customer shows a needle protruding from the side of the container.Resin is regularly punctured tested to ensure puncture resistance is over 2.8 lbf in accordance with specification requirements.Wall thickness is measured using statistical sampling.Review of in-process wall thickness inspections confirmed all wall thickness inspections were within specification.Autoclaving is designed to meet standards established by the cdc for autoclavable sharps containers.Without the product to evaluate, we are not able to conduct a more thorough investigation to determine a root cause.Based on the information available and the investigation findings, additional actions are deemed unnecessary at this time.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: 2 GAL CONTAINER, RED
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 11693520
• MDR Text Key: 262200538
• Report Number: 1424643-2021-00594
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 40884521023100
• UDI-Public: 40884521023100
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 31142222
• Device Catalogue Number: 31142222
• Device Lot Number: 20E09383
• Date Manufacturer Received: 04/18/2021
• Patient Sequence Number: 1