MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-SYR W/NDLE,SAFETY,27GX0.5", 1ML

Model Number	SYRS101272F
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle detached from the syringe when attempting to activity the needle safety feature.
Additional Manufacturer Narrative
It was reported that the needle detached from the syringe when attempting to activity the needle safety feature.The incident occurred after a nurse administered a tb test and the nurse reportedly experienced a needle stick injury.Following the injury, the puncture site was washed with soap and water and the nurse went to an emergency department for unspecified post-exposure diagnostic testing.Blood tests on the patient was reportedly negative for blood borne diseases.The nurse's test results were not disclosed, however, no serious injury, medical intervention, or other adverse impact was originally 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.No photo or sample were provided for evaluation.Testing was performed using retained samples from the reported product lot.The reported problem/issue was unable to be reproduced or confirmed and a root cause was unable to be determined.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Update made to section a3a.
Event or Problem Description
It was reported that the needle detached from the syringe when attempting to activity the needle safety feature.

• Common Device Name: DBD-SYR W/NDLE,SAFETY,27GX0.5", 1ML
• 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: 19056734
• Report Number: 1417592-2024-00350
• Device Sequence Number: 7330585
• Product Code: FMF
• UDI-Device Identifier: 40888277222480
• UDI-Public: 40888277222480
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2024

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 Model Number: SYRS101272F
• Device Lot Number: 14112120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 04/06/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Female