MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. HYPODERMIC NEEDLE-PRO® WITH SYRINGE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	4237
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Missed Dose (2561)
Date of Event	01/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Voluntary medwatch form #: mw5067465.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that a hypodermic needle-pro® needle detached during heparin administration to a patient.It was noted that the syringe disengaged prior to medication administration, and the medication was not successfully administered.No permanent injury was reported.

• Brand Name: HYPODERMIC NEEDLE-PRO® WITH SYRINGE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6381526
• Report Number: 3012307300-2017-00637
• Device Sequence Number: 552006
• Product Code: FMI
• UDI-Device Identifier: 30351688048831
• UDI-Public: 30351688048831
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K923127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/06/2017

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: Nurse
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 4237
• Device Lot Number: 3272537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2017
• Initial Report FDA Received Date: 03/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1