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

Model Number	31142222
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that the sharps container was received with the lip that the lid locks into broken off.There was no damage to the shipping box.
Additional Manufacturer Narrative
The device history record (dhr) review concluded that no abnormal process conditions were present during the manufacturing of this product that would lead to the reported condition.Samples were returned for analysis at the manufacturing facility; cracked rims were observed as reported.There was no consistency of the cavity number or side of the container where the cracked rim was observed.The damage most likely occurred during shipping and handling of the product by a distribution center.The customer reported on a previous complaint that items were received in a repacked box which is not indicative of the manufacturing process.Based on the investigation results, the reported condition¿s risk to patient/user and trending, no further actions are deemed necessary at this time.The issue will be monitored through routine complaint trend analysis and reviewed by a corrective/preventative action (capa) review board (crb) as necessary to determine if a capa requirement is necessary.

• 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: 12185382
• Report Number: 1424643-2021-00611
• Device Sequence Number: 16374880
• Product Code: MMK
• UDI-Device Identifier: 40884521023100
• UDI-Public: 40884521023100
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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: 20K19763
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/13/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 09/08/2021
• Patient Sequence Number: 1