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

Catalog Number	4286
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 jelco® hypodermic needle-pro® needle detached from the orange safety housing during injection attempt into the gluteal muscle of a patient.The depot injection was conducted by a certified pediatric nurse and the issue arose when the nurse pressed on the syringe plunger.The contents of the syringe leaked all over the patient's skin due to the issue.The nurse had to hold onto the needle and gently remove it from the patient.Another needle was used to administer the medication.No patient injury was reported.
Additional Manufacturer Narrative
One bag of sealed original kits of jelco® hypodermic needle-pro® device was returned for investigation (part number: 4286, lot number: 3141033).A review of the device history record found no discrepancies or anomalies relevant to the reported issue.During functional testing, a needle-pro® was inspected for disconnect; the sample stayed connected during testing.A review of all 49 packages was conducted and it was found that all samples were sealed properly.Investigation was unable to confirm the reported issue and therefore the root cause was unknown.
Additional Manufacturer Narrative
Investigation further concluded that the return samples functioned as designed and no fault was found with the returned devices.(conclusion code) - corrected information.

• 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: 6439307
• Report Number: 3012307300-2017-00779
• Device Sequence Number: 13637165
• 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: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2017

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 05/05/2017; 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1