MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC., DELTEC® GRIPPER® SAFETY NEEDLES; INTRAVASCULAR ADMINISTRATION SET.

Device Problems Activation, Positioning or Separation Problem (2906); Fail-Safe Problem (2936)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.

Event Description

The user facility reported that during the removal of the listed device from the patient, the safety mechanism could not be engaged over the needle.No needle-stick took place.No adverse health effects to the patient or nurse were reported.

• Brand Name: DELTEC® GRIPPER® SAFETY NEEDLES
• Type of Device: INTRAVASCULAR ADMINISTRATION SET.
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.,; 1265 grey fox road; st paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.,; 1265 grey fox road; st paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5684878
• MDR Text Key: 46081517
• Report Number: 2183502-2016-01097
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 05/27/2016
• 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: Initial
• Patient Sequence Number: 1