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

Model Number DYND20325

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/24/2023

Event Type  Injury  

Event 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".

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
• Type of Device: 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
• MDR Text Key: 318552734
• Report Number: 1417592-2023-00279
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• 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
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other