MAUDE Adverse Event Report: COVIDIEN MAGELLAN; SYRINGE, PISTON

Model Number	8881882812
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently under way; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reports a thin liquid in the syringe.
Additional Manufacturer Narrative
The customer reports a thin liquid in the syringe.The manufacturing site did not receive any samples or photographs for evaluation.Therefore, the reported issue could not be confirmed.The device history record for lot 608825x <(>&<)> 612434x was reviewed.This product was manufactured and the syringes were physically tested with 0 defects recorded relating to this customer report.The device history record for the lot control indicates that product and specification requirements were met with no non-conforming products identified relating to this customer report.Inspectors routinely examine the product to ensure it meets acceptable quality level (aql) sampling criteria.Some potential conditions that are inspected for include, but are not limited to water in assembled unit, damaged product or components, poor workmanship, particulates or extraneous matter in fluid pathway, and excessive lubricant.Molding processes are validated to ensure product quality during controlled processing.Preventative maintenance of the molding tool is conducted at required frequencies in order to ensure process capability is maintained.A lot cannot be released unless it passes all visual and physical testing requirements according to established aql standards.Without a representative sample(s) being provided, a more complete investigation cannot be performed to the full extent and the reported condition cannot be confirmed.In addition, without sample, a root cause cannot be determined at this time.Per procedure, complaint trends are evaluated during a monthly capa meeting to determine if a capa is warranted.At this time, there is not enough information and a capa will not be initiated.However, these conditions will be communicated to the appropriate manufacturing and quality assurance personnel.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MAGELLAN
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701 9062
• MDR Report Key: 6718461
• Report Number: 1915484-2017-05040
• Device Sequence Number: 11163959
• Product Code: FMF
• UDI-Device Identifier: 10884521005921
• UDI-Public: 10884521005921
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2018

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: Other
• Device Model Number: 8881882812
• Device Catalogue Number: 8881882812
• Device Lot Number: 612434X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 07/17/2017
• Supplement Report FDA Received Date: 01/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1