MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; SYRINGE, PISTON

Model Number	SY034E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported they are finding broken/missing luers.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
A sample was received at the plant for the investigation.The reported issue of a cracked barrel was observed.Leak testing was attempted, but the syringe would not draw water.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Based on the available information, an exact root cause could not be determined.The appropriate quality and manufacturing personnel will be notified of this complaint to heighten awareness of the reported condition.All information received will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Corrected the following sections: h2 selected device evaluation.H6 updated type of investigation codes.H10 updated additional manufacturer narrative.Corrected investigation summary: a sample was received at the plant for the investigation.The reported issue was observed.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Based on the available information, an exact root cause could not be determined.The appropriate quality and manufacturing personnel will be notified of this complaint to heighten awareness of the reported condition.All information received will be used for tracking and trending purposes.Corrected the following sections: h2 selected device evaluation.H6 updated type of investigation codes.H10 updated additional manufacturer narrative.

• Brand Name: CARDINAL HEALTH
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20278329
• Report Number: 1423537-2024-00160
• Device Sequence Number: 18013595
• Product Code: FMF
• UDI-Device Identifier: 50192253035924
• UDI-Public: (01)50192253035924(10)421524X
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K991758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2024

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: SY034E
• Device Catalogue Number: SY034E
• Device Lot Number: 421524X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/24/2024; 10/24/2024
• 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