MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-MEDIAL BRANCH PACK-LF

Model Number	PHS960421D
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	07/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that coring was observed after an unspecified solution was drawn into the syringe component.Reportedly, "a small plastic piece" was observed within the syringe barrel.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.The reporting facility returned a sample of a capped 5ml syringe with droplets of an unspecified solution and a capped 10ml syringe full of an unspecified solution.A small white particulate was observed within the 5ml syringe and a dark black/gray particulate was observed within the 10ml syringe.Although the samples were confirmed to have particulate, it could not be confirmed if the particulates were already inside of the syringe, if they came from the solutions that were drawn into the syringes, if the syringes were manufactured improperly causing the tip to core the vials, or if misuse of the syringes resulted in the syringe cutting into the vials and breaking off small particulates and it getting drawn into the components.A root cause was unable to be determined.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.
Event or Problem Description
It was reported that coring was observed after an unspecified solution was drawn into the syringe component.

• Common Device Name: DBD-MEDIAL BRANCH PACK-LF
• 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: 18865218
• Report Number: 1423395-2024-00151
• Device Sequence Number: 8239494
• Product Code: LRO
• UDI-Device Identifier: 40889942521280
• UDI-Public: 40889942521280
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 03/07/2024

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: PHS960421D
• Device Lot Number: 20HBV717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 03/08/2024
• 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