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

Model Number 8881112059

Device Problem Missing Information (4053)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 Description

The customer reported that some numbers and lines are missing from the syringes.

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
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 9940724
• MDR Text Key: 195256278
• Report Number: 1424643-2020-00574
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521010871
• UDI-Public: 10884521010871
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881112059
• Device Catalogue Number: 8881112059
• Device Lot Number: 19G25163X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/26/2020
• Patient Sequence Number: 1