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

Model Number	8881833558
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/07/2019
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 to the distributor that the needle was broken.According to the photograph provided, the hub was broken/detached from the syringe.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A review of maintenance records (both corrective and preventive) and calibration records were reviewed and there were no issues noticed.All scheduled maintenance and calibration activities were completed.There were no related process or material changes related to the reported condition for this product.Process monitoring data was reviewed for the assembly equipment and there were no issues related to the reported condition.A review of the machine setup was conducted and there were no issues found.A review of the manufacturing equipment was performed as part of this investigation.The review found no issues with the equipment or process related to the reported condition.There were no samples submitted with this complaint, however, a picture was provided for the evaluation.Upon visual evaluation, a fracture to the hub could be seen from the picture.The reported condition of a cracked hub is confirmed based on the picture provided.The exact root cause could not be determined based on available information.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 information will be utilized for trending purposes to determine the need for corrective actions.

• 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: 9341727
• Report Number: 1017768-2019-00735
• Device Sequence Number: 2801560
• Product Code: FMI
• UDI-Device Identifier: 10884521005846
• UDI-Public: 10884521005846
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/14/2020

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: 916325
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 02/14/2020
• Patient Sequence Number: 1