MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO® INSULIN SYRINGE WITH NEEDLE-PRO® EDGE¿ SAFETY HYPODERMINC NEEDLE; SYRINGE, ANTISTICK

Catalog Number ED12905-IN

Device Problems Bent (1059); Protective Measures Problem (3015)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/22/2018

Event Type  Injury  

Event Description

It was reported that after administering insulin to a patient, the nurse went to withdraw the needle and the needle "bent outside of the safety device" at a 90 degree angle.The nurse was stuck with the dirty needle.It was stated that medical intervention was required, however details of the intervention were not provided.

• Brand Name: JELCO® INSULIN SYRINGE WITH NEEDLE-PRO® EDGE¿ SAFETY HYPODERMINC NEEDLE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7620483
• MDR Text Key: 111710305
• Report Number: 3012307300-2018-02358
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 12/19/2022
• Device Catalogue Number: ED12905-IN
• Device Lot Number: 3553155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention