MAUDE Adverse Event Report: COVIDIEN 135 S-PLK X SP NO LOGO; SYRINGE, PISTON

Model Number 8881135019

Device Problem Contamination (1120)

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

Event Date 04/16/2021

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 that during inspection in the production line, the team detected syringe barrel has flash in the tip and there are burrs caught inside the barrel and plunger.There was no patient involved.

Manufacturer Narrative

The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.This product was manufactured on 13-july-2019 and packaged on july 14, 2019.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Two pictures have been provided for the evaluation.Upon visual evaluation, in the first picture, the length of a portion of the non-printed side of a syringe with unknown nominal capacity can be observed.There appears to potentially be minor skiving on the back side of the plunger rod or potentially loose plastic particulate.It is unknown if or what the exact condition is being presented from the photograph provided.In the second photograph, there appears to be damage incurred at the base of the luer.One potential root cause for the damaged luer and possible plastic debris within the barrel is the barrel may have been stuck on the core pin during the molding process.When this occurs, the barrel is subjected to multiple molding cycles which can smash and damaged the luer and create plastic particulate within the inner dimension of the barrel.Once the barrel breaks free, there is potential for it to be assembled and to proceed into finished product.The following control mechanisms are in place to prevent the occurrence of the reported condition during molding, printing, assembly, 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, assembly, 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, assembly, 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.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.Various validated detection units such as a rubber tip detection unit, plunger detection unit, barrel blow-out probe, and print tape break detectors are in place and verified at prescribed intervals to verify functionality.Air pressure for blow-over tubes were monitored and adjusted when necessary.Silicone settings are verified each shift of production to be within specification for timing, line pressure, head temperature, and blow temperature.Syringe samples are collected on a regular basis and submitted to the laboratory for silicone amount testing to verify silicone to be within validated specifications.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.This syringe is intended to be a single use syringe and not qualified as a prefill syringe.The manufacturing site did not receive any physical samples for the evaluation.Without a physical sample, a more complete investigation cannot be performed, and the control mechanisms are in place to prevent the reported issue from occurring therefore, it cannot be confirmed to be manufacturing-related.At this time, a corrective and preventive action is not deemed necessary.A quality alert will be distributed to all necessary quality and production personnel to heighten awareness of this reported condition.If additional information is obtained, or the sample is returned, this file will be re-opened for further investigation.This complaint will be used for tracking and trending purposes.G2 report source has been corrected
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• Brand Name: 135 S-PLK X SP NO LOGO
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11787246
• MDR Text Key: 255364634
• Report Number: 1915484-2021-01245
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521010819
• UDI-Public: 10884521010819
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881135019
• Device Catalogue Number: 8881135019
• Device Lot Number: 918244
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/16/2021
• Patient Sequence Number: 1