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

Device Problem Break (1069)

Patient Problem Underdose (2542)

Event Type  malfunction  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that a jelco hypodermic needle-pro needle broke, which resulted in the patient receiving partial dose of risperdal.An associated adverse event was reported.No permanent injury was reported.The healthcare professional provided demographics for four different patients: "first patient's age range was 18-34, the second patient's age range was 45-54, the third patient's age range was 55-64 and the fourth patient's age range was 65-74." it was reported that "3 were white and one was black." it is unknown to the healthcare professional which age, ethnicity or adverse event corresponded to which patient.See mfr: 2183502-2016-01947, 2183502-2016-01949, and 2183502-2016-01950.

• Brand Name: JELCO® HYPODERMIC NEEDLE-PRO® NEEDLE
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA,; 10 bowman drive; keene NH 03431 0724
• Manufacturer Contact: lisa perz ; 1265 grey fox rd.; st. paul, MN 51122 ; 7633833074
• MDR Report Key: 5940536
• MDR Text Key: 54401201
• Report Number: 2183502-2016-01946
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1