MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 20ML SYR L-LOCK; SYRINGE, PISTON

Model Number	1182000777
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
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 that the inner piece is breaking off at the luer-lock end.The threads stay but the inner straight piece breaks off.They were losing costly medications at the same time and had to dispose of the whole syringe and medication.Per additional information received on 01jun2022, there was no medical intervention required.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.During the manufacturing process, a sampling of devices were visually inspected and physically tested with no issues recorded relating to the customer report.One sealed unit carton containing 40 sealed packaged syringe assemblies were received at the manufacturing site for evaluation.A complete investigation was performed.Visual inspection to the quality inspection standard was conducted on all 40 samples and no issues were found relating to the reported condition.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.Per procedure, complaint trends are evaluated during a monthly corrective and preventative action (capa) meeting to determine if a capa is warranted.At this time, there is not enough information and a capa will not be initiated.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Correction made to h6 "type of investigation".

• Brand Name: MONOJCT 20ML SYR L-LOCK
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• 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: 14786391
• Report Number: 1915484-2022-01278
• Device Sequence Number: 17407881
• Product Code: FMF
• UDI-Device Identifier: 10884521010802
• UDI-Public: 10884521010802
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2022

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: 1182000777
• Device Catalogue Number: 1182000777
• Device Lot Number: 122119X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 05/31/2022; 05/31/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 07/18/2022; 07/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown