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

Model Number	HYPO NEDL-PRO 25G X 5/8"
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional contact: (b)(6).
Event or Problem Description
Information received a smiths medical sharps safety|jelco hypodermic needle-pro needle reported incident of" needle broke in patient's arm." additional information is being requested at this time, as intervention would be needed to remove needle from patients arm.
Additional Manufacturer Narrative
Other, other text: additional information- needle removed from patient with no adverse effects.Information added to section b5.
Event or Problem Description
Needle removed from patient with no adverse effects.

• Brand Name: JELCO HYPODERMIC NEEDLE-PRO NEEDLES
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC; 6000 lane n; minneapolis MN 55442
• MDR Report Key: 10880353
• Report Number: 3012307300-2020-11070
• Device Sequence Number: 16895377
• Product Code: FMI
• UDI-Device Identifier: 20351688046816
• UDI-Public: 20351688046816
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K923127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2020

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: Health Professional
• Device Expiration Date: 05/21/2025
• Device Model Number: HYPO NEDL-PRO 25G X 5/8"
• Device Catalogue Number: 4291
• Device Lot Number: 4002117
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/22/2020
• 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