MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-CATH LAB PACK

Model Number	DYNJ64937C
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a syringe component broke and that a physician was injured.
Additional Manufacturer Narrative
It was reported that a syringe component broke and that a physician was injured.Reportedly, it was the "wing" of the syringe the broke while injecting.The syringe was connected to a manifold at the time of the incident.The physician was reportedly "cut" during the incident, however, no serious injury or medical intervention was indicated.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.A sample was returned for evaluation and one "wing" was noted to be completed broken off.The edge where the breakage occurred appeared clean, indicating that it likely snapped off at once.No other damage or defects with the rest of the syringe was observed.A definitive root cause was unable to be determined, however, potential root causes include an issue with the component manufacturing process or rough handling during transit or storage.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

• Common Device Name: DBD-CATH LAB PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18880984
• Report Number: 1423395-2024-00295
• Device Sequence Number: 15413812
• Product Code: OES
• UDI-Device Identifier: 40195327219094
• UDI-Public: 40195327219094
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2024

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: DYNJ64937C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown