MAUDE Adverse Event Report: COVIDIEN 2.2 QT PHLEBOTOMY CONT; CONTAINER, SHARPS

Model Number	1522SA
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2019
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 the lid doesn't fit on the sharps container.
Additional Manufacturer Narrative
The device history record (dhr) file was reviewed indicating that the product was released meeting all quality standard requirements.A sample was returned to the manufacturing plant.The evaluation determined that the lid returned was not a lid manufactured at the cardinal health facility.The reported condition could not be confirmed.There was one potential root cause identified during the investigation which pertain to be a user error, either at the customer level or the distribution level.Based on the information available and the investigation findings, a formal investigation is not deemed necessary at this time.

• Brand Name: 2.2 QT PHLEBOTOMY CONT
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 8628689
• Report Number: 1424643-2019-00538
• Device Sequence Number: 16686496
• Product Code: MMK
• UDI-Device Identifier: 10884521023468
• UDI-Public: 10884521023468
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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
• Operator of Device: No Information
• Device Model Number: 1522SA
• Device Catalogue Number: 1522SA
• Device Lot Number: 00176777
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 10/18/2019
• Patient Sequence Number: 1