MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-SYRINGE, SAFETY, INS, 1ML, 29G X 1/2

Model Number SYRS101292

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/28/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that a needle broke off of the syringe while medication was being administered by a nurse.According to the unit manager, the device is new to the staff and the nurse "had difficulty using the product to draw the insulin and feels the needle may have bent in the process." after the needle broke off, it was reportedly removed from the patient's arm.A syringe-specific defect was not indicated at the time of the originally report and no serious injury or adverse impact to a patient or a user was reported.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.Two (2) samples in new condition were returned for evaluation.Visual and functional testing was unable to reproduce or confirm the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on 22-jan-2024, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a needle broke off of the syringe during use.

• Type of Device: DBD-SYRINGE, SAFETY, INS, 1ML, 29G X 1/2
• 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: 18966558
• MDR Text Key: 338560612
• Report Number: 1417592-2024-00211
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SYRS101292
• Device Lot Number: (10)89722090001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Date Manufacturer Received: 02/28/2023
• 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