MAUDE Adverse Event Report: COVIDIEN 1ML TB SYRINGE REGULAR LUER RP; SYRINGE, PISTON

Model Number 8881501400

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 05/20/2021

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 the plunger is very hard to move.

Manufacturer Narrative

Investigation summary: a device history record (dhr) review confirmed that the product was produced accomplishing quality requirements and released according to established procedures.Eighty-seven packaged samples were received for evaluation.A complete investigation was performed.Visual inspection to the quality inspection standard was conducted.No failures were observed.A plunger activation force test was completed on a statistical sample size of 32 pieces.The result for the plunger movement force ranged from 0.47 ¿ 0.94 lbf.Results pass the specification of not more than 1.124 lbf average return force.The reported issue was not confirmed therefore the exact root cause could not be identified however the following are possible root causes for tight plunger action: uneven silicone on the rubber tip or the barrel, a plugged/occluded cannula, insulin crystallization or improper technique used by the end user; exercising the plunger in the barrels prior to use will redistribute the silicone and make the plunger action easier.These syringes are designed to be a single use syringe.The following control mechanisms are in place to prevent the occurrence and acceptance of the reported condition during molding, printing, and packaging processes, and to ensure components and finished product meet all quality inspection standards during the syringe assembly processes.The manufacturing site maintains material verification processes.The raw materials must pass an inspection and certification review before release to the floor for production.The manufacture of all molded components is conducted within a validated process inside a controlled manufacturing area.The critical dimensions of the molded components are gauged to ensure molded components meet dimensional specifications and are visually and physically tested for adherence to the quality inspection standard.If problems were detected during processing, non-conforming product would be identified and segregated.Molding, printing, and packaging machine maintenance requirements are documented.Records of maintenance activities are maintained.Personnel are trained and certified in the operation of the molding, printing, and packaging equipment.Personnel are trained and certified in the process of product evaluation and documentation requirements.During manufacturing, process inspectors inspect product at periodic intervals to ensure it meets acceptable quality limits.Process inspectors are required to conduct visual and physical evaluations at prescribed intervals and cannot release product unless the required aql has been met per the specification.Occluded cannula detectors are installed on the assembly machines and are checked each shift to ensure that they are working properly.The plunger is exercised during the assembly process to distribute the silicone in the barrel and on the rubber tip.Leak testing is conducted to ensure the syringe draws, holds and expels fluid properly.The product is also tested to assure that the needle contains sufficient lubrication for ease of needle insertion during use.Periodic audits are conducted to ensure the quantity of barrel i.D.Silicone is within specification limits.Procedures and standard work instructions exist for the set-up, operation, and maintenance of the molding machines and assembly machines.Cleaning and maintenance requirements are defined and implemented to ensure continuing process capability.All lots and shop orders are visually and physically inspected to the quality inspection standard and the statistical sampling must meet the acceptable quality limit requirements during the molding and assembly process.A lot cannot be released unless it passes specification requirements.Based on the information available and the investigation findings, a corrective action is not deemed necessary at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: 1ML TB SYRINGE REGULAR LUER RP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11889218
• MDR Text Key: 255364437
• Report Number: 1915484-2021-01253
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521014053
• UDI-Public: 10884521014053
• 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: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881501400
• Device Catalogue Number: 8881501400
• Device Lot Number: 034277
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/21/2021
• Patient Sequence Number: 1