MAUDE Adverse Event Report: COVIDIEIN 1ML TB SYR 25G X 5/8 DETACH RP; SYRINGE, PISTON

Model Number 8881501160

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 06/14/2019

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 states the needles are not securely attached to the syringe when removed from the box and the needle looks bent.When they try to remove the needle to replace it, the hub cracks and the needle detaches.This was noticed before use.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.One unpackaged sample was received at the plant for the investigation.Visual inspection to the quality inspection standard was conducted and the reported condition was confirmed, the luer taper was broken off the syringe.No other defects were identified.There was no hooded needle assembly included with the sample received.Without being provided a sample of the hooded needles and the broken tips that were involved in relation to this reported condition, a complete investigation cannot be performed at this time and the root cause cannot be definitively identified as a manufacturer related defect.The following control mechanisms are in place to prevent the occurrence and acceptance 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 plant 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 are 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.Operators are instructed to inspect all product used for regrind activities for potential contaminants such as color, rubber tips, cannula, or inclusions to assure it is clean before regrinding.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.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.However, these conditions will be communicated to the appropriate manufacturing and quality assurance personnel.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 1ML TB SYR 25G X 5/8 DETACH RP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEIN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 8723042
• MDR Text Key: 149078414
• Report Number: 1915484-2019-01059
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 20884521013954
• UDI-Public: 20884521013954
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881501160
• Device Catalogue Number: 8881501160
• Device Lot Number: 902823
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/17/2019
• Patient Sequence Number: 1