MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SYRINGE, LUER LOCK, STERILE, 5ML

Catalog Number	SYR105010
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the doctor was performing an excision of an ingrown toenail on the left great toe when the plunger of the syringe broke at the beginning of the procedure.The physician stated that he did not experience any issues drawing up the lidocaine from the vial, however when he had the needle in the toe and he pushed down on the plunger, the shaft of the syringe bent sideways and the plunger was unable to be pushed forward to expel the medication.There was no lidocaine injected into the patient's toe, however a new syringe was required to complete the procedure.The physician completed the injection and the excision without further incident.The actual sample was returned for evaluation and the customer reported issue of a broken plunger was confirmed during evaluation and found to be due to excessive force.No additional information is available at this time.There was no further intervention required for the patient.There was no follow-up medical care or additional medical intervention required related to the incident, however medical intervention to replace the initial syringe to complete the procedure was necessary.Due to the reported incident and 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.
Event or Problem Description
It was reported that the plunger of the syringe broke at the beginning of the procedure resulting in a new syringe to complete the procedure.

• Common Device Name: SYRINGE, LUER LOCK, STERILE, 5ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8915646
• Report Number: 1417592-2019-00126
• Device Sequence Number: 16771787
• Product Code: FMF
• UDI-Device Identifier: 10080196310173
• UDI-Public: 10080196310173
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/21/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SYR105010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Patient Weight: 91