MAUDE Adverse Event Report: COVIDIEN 3/10CC E100 SAF 29X1/2; SYRINGE, PISTON

Model Number	8881511144
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One unsealed package sample was received for investigation.A complete investigation was performed.The sample was received with a yellow insulin lispro 100 units/ml tag adhered to the syringe near the syringe barrel finger flange and the plunger rod and rubber tip was extended inside the syringe barrel.The visual inspection according to the quality inspection standard was conducted.The syringe was missing the ¿0¿ of the numeral ¿20¿ and all graduation lines and printing below the numeral ¿20¿ was identified on the syringe sample.The safety shield was extended for evaluation of the cannula.The cannula was bent over between the syringe barrel trident and the safety collar.The device history record was reviewed, and the shop orders indicate that product and specification requirements were met with no non-conforming product identified relating to this customer report.There is a potential for the condition of a bent needle to occur when the cannula is introduced to the needle assembly, if it is placed at an angle or catches on something throughout the epoxy sealing of the needle placement causing the needle to become off-center, the sheath could potentially bend the needle over as it is being applied to the assembly.The most probable root cause for the missing barrel print is attributed to further handling and/or use of the syringe.This is not deemed to be a manufacturing-related defect.When taking into consideration all inspection results noted throughout the manufacture of the lot, the overall lot would be accepted to be manufactured per established quality specifications.These conditions will be communicated to the appropriate manufacturing and quality assurance personnel to heighten awareness of the conditions found and reported.
Event or Problem Description
The investigation findings determined that the syringe was missing graduation lines.
Additional Manufacturer Narrative
Section g4: initially reported as 13-dec-2019 and the correct date should be 12-dec-2019.

• Brand Name: 3/10CC E100 SAF 29X1/2
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9569142
• Report Number: 1915484-2020-01118
• Device Sequence Number: 438677
• Product Code: FMF
• UDI-Device Identifier: 20884521014951
• UDI-Public: 20884521014951
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2020

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?: No
• Operator of Device: No Information
• Device Model Number: 8881511144
• Device Catalogue Number: 8881511144
• Device Lot Number: 913350X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2020
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 01/09/2020
• Patient Sequence Number: 1