MAUDE Adverse Event Report: COVIDIEN 12ML SYRINGE REGULAR NS; SYRINGE, PISTON

Model Number	8881112059
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 some numbers and lines are missing from the syringes.
Additional Manufacturer Narrative
H 3 evaluation summary a device history record (dhr) review was completed for the reported lot.There were no manufacturing related issues related to the complaint issued for this lot.Samples were received for evaluation and were visually inspected.Intermittently missing gradient print were found, and the reported condition was confirmed.The most probable cause of the reported issue is that a jam at the printer occurred.Studies on the effectiveness of inspection have been completed to ensure associates can identify issues to established acceptance criteria.Based on the information available and the investigation findings, additional actions are deemed unnecessary at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: 12ML SYRINGE REGULAR NS
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 9940724
• Report Number: 1424643-2020-00574
• Device Sequence Number: 16967294
• Product Code: FMF
• UDI-Device Identifier: 10884521010871
• UDI-Public: 10884521010871
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/14/2020

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: 8881112059
• Device Catalogue Number: 8881112059
• Device Lot Number: 19G25163X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 05/14/2020
• Patient Sequence Number: 1