MAUDE Adverse Event Report: COVIDIEN MAGELLAN 3ML SFTY COMBO 25X5/8; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881833558
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/30/2019
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 that the syringes were found detached from the luer inside of the package before the product was opened.
Additional Manufacturer Narrative
A review of the device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.A sample was not returned to the manufacturing site for evaluation however a photograph was submitted with the complaint report.An examination of the photograph demonstrates that the needle hub appears to be detached from the syringe.A specific root cause could not be determined without an actual sample to examine and there were no related issues found in a review of manufacturing records.There was no indication of a systemic issue with the process or production.Based on available information, no corrective actions are required at this time.This complaint will be closed with no further action.If sample is received later, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: MAGELLAN 3ML SFTY COMBO 25X5/8
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9285627
• Report Number: 1017768-2019-00725
• Device Sequence Number: 18872883
• Product Code: FMI
• UDI-Device Identifier: 10884521005846
• UDI-Public: 10884521005846
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 03/25/2020

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: 8881833558
• Device Catalogue Number: 8881833558
• Device Lot Number: 907744
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 03/25/2020
• Patient Sequence Number: 1