MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 60ML SYR L-LOCK; SYRINGE, PISTON

Model Number	1186000777
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported a piece of plastic adhered to the black plunger face on the fluid path side of the plunger.
Additional Manufacturer Narrative
Investigation summary: the device history record (dhr) for lot 122126x was reviewed.This product packaged on august 8-9, 2021.During the packaging of this lot, pieces were visually inspected and physically tested with no failures recorded relating to this reported condition.The dhr for the lot control and the shop order indicate that product and specification requirements were met with no non-conforming product identified relating to this report.The manufacturing site was provided with three representative photographs.In each photograph provided, a portion of the length of a syringe can be observed.The plunger rod is slightly pulled back in each photograph to approximately the 10 ml graduation and a large section of plastic can be observed on the rubber tip.The exact measurement of the plastic piece is unknown but can be confirmed to be large enough that it would not pass through the fluid pathway.The manufacturing site did not receive any physical samples with this report.Without a physical sample, a more complete investigation cannot be performed and the issue cannot be confirmed to be manufacturing-related and an exact root cause could not be determined.There are control mechanisms 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 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.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.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.At this time, there is not enough information and a capa will not be initiated.However, these conditions will be communicated to the appropriate manufacturing and quality assurance personnel for awareness.This complaint will be used for tracking and trending purposes.

• Brand Name: MONOJCT 60ML SYR L-LOCK
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer (Section G): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12771655
• Report Number: 1915484-2021-01264
• Device Sequence Number: 11825700
• Product Code: FMF
• UDI-Device Identifier: 10884521010864
• UDI-Public: 10884521010864
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1186000777
• Device Catalogue Number: 1186000777
• Device Lot Number: 122126X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 11/08/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown