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

Model Number 982312D

Device Problems Difficult to Fold, Unfold or Collapse (1254); Difficult to Open or Close (2921)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

Event 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
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11795359
• MDR Text Key: 249671878
• Report Number: 3012307300-2021-04097
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 20351688081770
• UDI-Public: 20351688081770
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K895705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1