MAUDE Adverse Event Report: COVIDIEN MAGELLAN; SYRINGE, PISTON

Model Number	8881893050
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 1/31/2018.An investigation is currently under way; upon completion the results will be forwarded.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reports the inscriptions on the syringe were not visible and the product was still in the package.
Additional Manufacturer Narrative
Product id: 8881893050 lot no: 714519x.The manufacturing site received one unpackaged sample with this customer report.A complete investigation was performed.The sample was received with the safety shield extended and in the locked position.A visual inspection to the quality inspection standard was conducted.The inspection of the syringe barrel identified missing and illegible print.The barrel printing was illegible and missing the first digit on each of the unit marks, and there were no graduation lines.A device history record review of the reported lot number(s) confirmed that the product was produced accomplishing quality requirements and released according to established procedures.A definitive root cause was not determined, but the potential root cause identified several possible contributing factors to the reported condition to: missing print may result if the print pad to barrel timing was not correct.The print pad may have gotten damaged or worn.If the viscosity of the ink was incorrect, it may cause the print to not properly transfer.Significant handling of the syringe barrel can result in reduction of print clarity and print presence.These syringes are designed to be a one-time use only syringe.Repeated use of the syringe could smear or wear off the print.During production, the processing equipment is checked regularly to verify that the systems are functioning properly.All lots and shop orders are visually and physically inspected to the quality inspection standard, and the statistical sampling must meet the acceptance quality level requirements during the molding, printing, and assembly process.During manufacturing inspectors routinely examine product to ensure it meets acceptable quality levels.A lot cannot be released unless it passes all specification requirements.All lots and shop orders are visually and physically inspected to the quality inspection standard, and the statistical sampling must meet the acceptance quality level requirements.Per procedure, complaint trends will be evaluated during the monthly meeting to determine if a formal corrective/preventative action (capa) is warranted.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: 7230565
• Report Number: 1915484-2018-00003
• Device Sequence Number: 19203936
• Product Code: FMF
• UDI-Device Identifier: 30884521005970
• UDI-Public: 30884521005970
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

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 Expiration Date: 04/30/2022
• Device Model Number: 8881893050
• Device Catalogue Number: 8881893050
• Device Lot Number: 714519X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1