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

Model Number	DYNJ69094A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a control syringe component was "defective.".
Additional Manufacturer Narrative
It was reported that a control syringe component was "defective." no information was provided on what type of defect was observed or how the control syringe component was being used at the time of the incident.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 no defects or issues were identified during the course of the evaluation.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.
Additional Manufacturer Narrative
Update to e1: first name, last name, telephone number, email address update to g3: date received by manufacturer.Update to manufacturer narrative(h11): the reporting facility indicated that there have been multiple incidents where the control syringe component "disconnects on its own and introduces air into the tubing".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 no defects or issues were identified during the course of the evaluation.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 - NAMIC; 10 glens falls technical park; glens falls NY 12801 3864
• Manufacturer Contact: danielle pohlman ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18881182
• Report Number: 1423395-2024-00319
• Device Sequence Number: 9049346
• Product Code: OES
• UDI-Device Identifier: 40195327341955
• UDI-Public: 40195327341955
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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: DYNJ69094A
• Device Lot Number: 23FBL314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 03/12/2026
• 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