MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; SYRINGE,PISTON,IRRIGATION,60ML,STERILE

Model Number	DYND20325
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2023 "the piston syringe was being used for irrigation during a procedure in which the protective tip unknowingly became dislodged from the syringe when it was used".
Additional Manufacturer Narrative
According to the facility on (b)(6) 2023 "the piston syringe was being used for irrigation during a procedure in which the protective tip unknowingly became dislodged from the syringe when it was used".Per the facility "within 12 hours the patient developed symptoms consistent with neurological injury and the patient was returned to the or to remove the protective tip".No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: SYRINGE,PISTON,IRRIGATION,60ML,STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17259625
• Report Number: 1417592-2023-00279
• Device Sequence Number: 7911672
• Product Code: KYZ
• UDI-Device Identifier: 10080196031863
• UDI-Public: 10080196031863
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DYND20325
• Device Catalogue Number: DYND20325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 09/12/2023
• 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