MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; SYRINGE, PISTON

Lot Number 2020070890

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  Injury  

Event Description

Patient was in imaging for a right hip injection.While providers was superficially numbing the area, the wing from the 10ml syringe broke off.The syringe was included in the arthrogram kit.As provider attempted to push the lidocaine through the syringe, the syringe pushed into the patient.The needle bent at this time.Nothing broke off in the patient and the patient was not injured.The arthrogram tray was from medline.Lot #2020070890, reorder (b)(4).Fda safety report id # (b)(4).

• Brand Name: MEDLINE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 11046079
• MDR Text Key: 223188159
• Report Number: MW5098464
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/17/2020

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 Operator: Health Professional
• Device Lot Number: 2020070890
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 73