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

Model Number	8881833558
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/07/2020
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 syringe barrel was cracked.
Additional Manufacturer Narrative
The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A review of maintenance records (both corrective and preventive) and calibration records were reviewed and there were no issues.All scheduled maintenance and calibration activities were completed.There were no process related or material related changes to the reported condition for this product.The 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.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 was one (1) opened sample returned for the evaluation.The customer also provided a picture for evaluation.The sample was missing the needle sub-assembly; however, the barrel can be seen with an internal fracture along its length.Therefore, the reported condition is confirmed.The exact root cause of the reported condition 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 actions are required at this time.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.Specifically, samples are examined for damage and leaks.The lot met all defined acceptance requirements and was released.This complaint will be used for qa 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: 9763592
• Report Number: 1017768-2020-00800
• Device Sequence Number: 16791213
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: 922497
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 04/14/2020
• Patient Sequence Number: 1