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

Model Number	982312D
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Difficult to Open or Close (2921)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a blood borne pathogen exposure because the butterfly needle sheath split apart exposing the dirty needle, breaching their glove and piercing her index finger.No further adverse patient effects were reported.

• Brand Name: JELCO
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• MDR Report Key: 11795359
• Report Number: 3012307300-2021-04097
• Device Sequence Number: 3181900
• Product Code: FMI
• UDI-Device Identifier: 20351688081770
• UDI-Public: 20351688081770
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K895705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2021

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 Model Number: 982312D
• Device Catalogue Number: 982312D
• Device Lot Number: 4113954
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 05/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1