MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC JELCO® HYPODERMIC NEEDLE-PRO® EDGE¿ SAFETY DEVICE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	4286
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer stated that device will not return to the manufacturer for device evaluation.If the device becomes available, 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 while using the hypodermic needle pro in the intramuscular (gluteal muscle) the plunger seepage was noted and on withdrawal from buttock the needle detached from the needle protection device.Therefore needle was then removed, nursing staff unable to tell how much of depot was actually given due to seepage and needle breaking off.No physical injury noted.

• Brand Name: JELCO® HYPODERMIC NEEDLE-PRO® EDGE¿ SAFETY DEVICE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6337358
• Report Number: 3012307300-2017-00490
• Device Sequence Number: 19091806
• Product Code: FMI
• UDI-Device Identifier: 30351688046790
• UDI-Public: 30351688046790
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K923127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/24/2017

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
• Operator of Device: Nurse
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 4286
• Device Lot Number: 3141033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2017
• Initial Report FDA Received Date: 02/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1