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

Model Number 4291

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 05/24/2018

Event Type  malfunction  

Event Description

The needle comes off from the threaded hub when aspirating sterile diluent.

• Brand Name: JELCO
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7560367
• MDR Text Key: 109785375
• Report Number: 7560367
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Expiration Date: 10/23/2022
• Device Model Number: 4291
• Device Lot Number: 3520819
• Other Device ID Number: HYPODERMIC NEEDLE-PRO 25G 5/8
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2018
• Date Report to Manufacturer: 05/29/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1