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

Model Number	31142222
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Customer reports: the 1ml tuberculin syringe poked out of the sharps container after it was autoclaved.
Additional 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.
Additional Manufacturer Narrative
Update section d4: lot number added based on the customer provided photo.

• Brand Name: 2 GAL CONTAINER, RED
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 11693520
• Report Number: 1424643-2021-00594
• Device Sequence Number: 3909259
• Product Code: MMK
• UDI-Device Identifier: 40884521023100
• UDI-Public: 40884521023100
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2021

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
• Operator of Device: No Information
• Device Model Number: 31142222
• Device Catalogue Number: 31142222
• Device Lot Number: 20E09383
• Initial Date Received by Manufacturer: 04/18/2021
• Supplement Date Received by Manufacturer: 04/18/2021; 04/18/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 04/20/2021; 08/10/2021
• Patient Sequence Number: 1