MAUDE Adverse Event Report: SMITHS MEDICAL NORTH AMERICA DELTEC GRIPPER MICRO BLUNT CANNULA NON-CORING SAFETY NEEDLE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-3256-24

Device Problems Difficult or Delayed Activation (2577); Protective Measures Problem (3015)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/22/2015

Event Type  malfunction  

Event Description

Throughout the pediatric unit nurses have been complaining of the safety needle not easily engaging its safety mechanism.The needle is designed to be removed from the patient while the bottom of the unit remains in contact with the patient.This creates an opening effect with the hinge being in distal from the needle.As the unit opens the needle is pulled through a port.When the needle is all the way through the port the tension that the needle is under from being curved during the opening of the hinge is released and the needle snaps into a safety position.The needle point is then securely wedged above the port section of the unit.This prevents nursing from sticking themselves with the needle once it is removed.Because so much resistance is being met by opening the hinge and pulling the needle through the port, the needle is being removed from the patient without having opened the device all the way.This results in the needle tip being exposed.One such occurrence resulted in a nurse being poked with the needle.No harm came to the nurse that was poked.Nursing, even experienced nurses, say that these needles are more difficult to open than they have been in the past.Quality assurance file opened.Mfr sent a shipping label to return the two reference and lot numbers for which we have been having the problems with and will await failure analysis.

• Brand Name: DELTEC GRIPPER MICRO BLUNT CANNULA NON-CORING SAFETY NEEDLE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL NORTH AMERICA; 10 bowman dr; keene NH 03431
• MDR Report Key: 5210515
• MDR Text Key: 30717536
• Report Number: 5210515
• Device Sequence Number: 1
• Product Code: FPA
• 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: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 21-3256-24
• Device Lot Number: 34X782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/27/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other