MAUDE Adverse Event Report: COVIDIEN MONOJECT 8 QT CT CONT - RED; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881676285
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2021
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
Customer reports: the container cannot be sealed when it is fully loaded because the red cap that is used to seal the container is missing.

• Brand Name: MONOJECT 8 QT CT CONT - RED
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11207832
• Report Number: 1282497-2021-09862
• Device Sequence Number: 3616859
• Product Code: FMI
• UDI-Device Identifier: 10884521018860
• UDI-Public: 10884521018860
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/21/2021

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: 8881676285
• Device Catalogue Number: 8881676285
• Device Lot Number: 615058
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 01/21/2021
• Patient Sequence Number: 1