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

Catalog Number	4293
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Information (3190)
Date of Event	07/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information regarding the event has been requested, but not yet received.
Event or Problem Description
It was reported that the needle of a jelco® hypodermic needle-pro® device "broke off".It was noted that an adverse event occurred, however details of the event were not provided.
Additional Manufacturer Narrative
One box with 25 sealed jelco® hypodermic needle-pro® devices was received for investigation.Visual inspection of the devices did not reveal any defects or anomalies.No breakage or bent components were observed.A possible explanation for what the reporter described as "the needle broke off" may have occurred as a result of not tightening the needle to the needle-pro® and the needle-pro® to the syringe prior to use.Functional testing was performed and no leaking, separation, or breakage of the components were observed.The complaint was not confirmed, and no root cause was determined.
Event or Problem Description
It was additionally reported that the device was in use for joint injections in the knee with the drug orthovisc.The plastic part at the base of the needle broke causing the needle to stay in the patient's knee.The needle was able to be removed without harm.

• 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: 6797958
• Report Number: 3012307300-2017-01832
• Device Sequence Number: 531619
• Product Code: FMI
• UDI-Device Identifier: 20351688058901
• UDI-Public: 20351688058901
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 04/26/2022
• Device Catalogue Number: 4293
• Device Lot Number: 3416022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 09/01/2017; 09/15/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 09/18/2017; 09/27/2017
• 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