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

Model Number	8881833558
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 their distributor that two syringe/needle combos hubs were cracked and broken off from the syringe.
Additional Manufacturer Narrative
Additional information: the device history record (dhr) for the lot indicates no issues were found in visual and physical samples inspected.There were no nonconformance reports (ncr) issued against this lot.All scheduled maintenance and calibration activities were completed.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.The lot met the acceptance criteria and was released.There were no samples returned with this complaint, however, pictures were sent by the customer illustrating the reported condition.The reported condition of cracked hub was confirmed based on the pictures.The complaint shall be reopened if a sample is received.An exact root cause could not be determined based on the available information.There was no indication of a systemic issue with the process or production.Based on available information, no corrective and preventative action (capa) is required at this time.This information will be utilized for trending purposes to determine the need for corrective actions.Please note: to date we have not received a product sample for evaluation.If a product sample is available, please forward it and the investigation will be updated.

• 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: 9356803
• Report Number: 1017768-2019-00739
• Device Sequence Number: 11286044
• 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): 02/17/2020

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: 11/08/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 02/17/2020
• Patient Sequence Number: 1