MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD. JELCO HYPODERMIC NEEDLE-PRO SAFETY NEEDLE

Catalog Number 4236

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

Event Description

The user facility reported that the needle became loose after use with a patient.The needle reportedly became detached from the syringe which resulted in a needle-stick, sustained by the clinician.The clinician is believed to be receiving treatment consistent with the facility's internal protocol for blood exposure.No permanent adverse effects to the clinician have been reported.There was no patient injury reported.Additional information has been requested; none is available at this time.

Manufacturer Narrative

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

• Brand Name: JELCO HYPODERMIC NEEDLE-PRO SAFETY NEEDLE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.; hythe, kent
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman drive; keene NH 03431
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 4118187
• MDR Text Key: 4941121
• Report Number: 2183502-2014-00670
• Device Sequence Number: 1
• Product Code: FMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 4236
• Device Lot Number: 2731830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Unknown
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2014
• Device Age: 2 MO
• Event Location: Hospital
• Date Manufacturer Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• 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
• Patient Outcome(s): Other