MAUDE Adverse Event Report: COVIDIEN 1ML TB SYR 25G X 5/8 DETACH RP; SYRINGE, PISTON

Model Number	8881501160
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the device history record (dhr) for the reported lot was reviewed.During the manufacturing of the syringe assemblies, syringes were visually and physically tested with no issues recorded relating to this customer report.The dhr for the lot control indicates that product and specification requirements were met with no non-conforming product identified relating to this customer report.The manufacturing site received sealed, packaged syringe samples and unsealed, packaged samples identified with the reported lot.A complete investigation was performed.Visual inspection of the samples identified smeared and illegible numerals and graduation lines on one of the syringe samples and a missing graduation line was identified on another syringe sample.An adjustment to the timing of the printer setup is made at start-up and any time after changing the print pad.The barrel printer automatically scraps start-up production until the process is stable.Evaluation of print adhesion is conducted with a tape test and the ink viscosity is monitored and controlled within a validated range.Associates are required to verify that the barrel print meets the quality inspection standard at the start-up of the process and at prescribed intervals throughout the length of the production.The issue of smeared and illegible or missing print can be due to misalignment of the print assembly or ink may have been compromised as barrels are being transferred throughout the assembly following the barrel print being applied.A quality alert will be distributed to all necessary quality and production associates to heighten awareness of the potential for smeared/illegible and missing barrel print.Complaint trends are evaluated during the monthly corrective and preventative action (capa) meeting to determine if a capa is warranted.At this time, a capa will not be initiated.This complaint will be used for tracking and trending purposes.
Event or Problem Description
Upon investigation at the manufacturing plant, two syringes provided for analysis from a customer were discovered to have varying degrees of smeared/illegible and missing barrel print and graduation marks.
Additional Manufacturer Narrative
A device history record (dhr) review of the reported lot no.902816x confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The manufacturing site received two hundred sixty-one (261) sealed package syringe samples and seven (7) unsealed package samples identified with lot 920347x.The visual inspection of the sealed packaged syringe identified smeared and illegible numerals and graduation lines on one of the syringe samples.One additionally syringe sample was missing the graduation line.The visual inspection of the unpackaged samples from lot 920347x identified zero (0) defects.Silicone amount testing was completed on a random representative 10-piece sample from the samples provided.All results confirmed silicone was present and did not exceed the maximum silicone allowed.The condition of smeared and illegible or missing print can be due to misalignment of the print assembly or ink may have been compromised as barrels are being transferred throughout the assembly following the barrel print being applied.An adjustment to the timing of the printer setup is made at start-up and any time after changing the print pad.The barrel printer automatically scraps start-up production until the process is stable.Evaluation of print adhesion is conducted with a tape test and the ink viscosity is monitored and controlled within a validated range.Associates are required to verify that the barrel print meets the quality inspection standard at start-up of the process and at prescribed intervals throughout the length of the production.

• Brand Name: 1ML TB SYR 25G X 5/8 DETACH RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9727188
• Report Number: 1915484-2020-01131
• Device Sequence Number: 2482700
• Product Code: FMF
• UDI-Device Identifier: 20884521013954
• UDI-Public: 20884521013954
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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: 8881501160
• Device Catalogue Number: 8881501160
• Device Lot Number: 920347X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: 01/27/2020
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 05/12/2020
• Patient Sequence Number: 1