MAUDE Adverse Event Report: COVIDIEN 1/2CC E100 SAF 29X1/2; SYRINGE, PISTON

Model Number 8881511136

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 the safety lock is not good, and it does not lock properly.The issue was discovered when the needles were tested after opening the box.There was no patient involved.

Manufacturer Narrative

A device history record confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The manufacturing site received 112 packaged samples with this customer report.A complete investigation was performed.A visual inspection to the quality inspection standard was conducted.A statistical sample size of 50 pieces was tested for the following: shield extend testing, shield retract testing, shield locking torque testing, and shield collar/spin testing.These tests were selected as they would best examine whether the safety mechanism of the syringes worked properly.All testing completed on the returned samples met specifications.As per the ifu the plastic shield on the safety syringe is designed to slide forward to cover the needle to prevent needle sticks and the safety mechanism will deactivate if you do not pull the shield up all the way and twist it.Based on the description provided by the customer, it is possible that the issue occurred when attempting to activate the safety mechanism if there was any deviation to the manner of activating the safety feature.Process controls are in place to prevent the occurrence and acceptance of the reported conditions during the molding, printing, assembly, and packaging processes, and to ensure components and finished product that meet all quality inspection standards during the syringe assembly processes.In compliance with corporate and local procedures, safeguards are utilized to ensure all processes are controlled and cleaned regularly to minimize any process or product contamination.The control mechanisms are located at the plant and are confirmed on a regular basis to verify continuing efficacy.

• Brand Name: 1/2CC E100 SAF 29X1/2
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11680441
• MDR Text Key: 247931594
• Report Number: 1915484-2021-01231
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 20884521014944
• UDI-Public: 20884521014944
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881511136
• Device Catalogue Number: 8881511136
• Device Lot Number: 033918X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/13/2021
• Patient Sequence Number: 1