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

Catalog Number	4293
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported on (b)(6) 2017 that the event occurred "sometime last week".The exact date is unknown.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 the needle of a jelco® hypodermic needle-pro® device detached from the safety housing upon attempting to remove after injection.The needle broke off inside the patient's muscle and the doctor had to pull it out by hand.No injury to patient or clinician was reported.
Additional Manufacturer Narrative
One box with 90 unused samples of the same lot were returned for evaluation.Visual inspection of all devices did not show disconnection.Functional testing involved 45 of the unused samples in a simulated use test and showed no disconnection.Functional testing also involved 5 of the unused samples in a iso standard (b)(4) and showed that all samples passed.Based on the evidence, no fault was found and the root cause of the reported issue was unable to be determined.

• Brand Name: JELCO® HYPODERMIC NEEDLE-PRO® 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: 6567163
• Report Number: 3012307300-2017-01029
• Device Sequence Number: 1306196
• Product Code: FMI
• UDI-Device Identifier: 20351688058901
• UDI-Public: 20351688058901
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K923127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2017

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: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 4293
• Device Lot Number: 3281293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2017
• Supplement Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1