MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC GRIPPER MICRO; HUBER NEEDLE

Catalog Number 21-3277-24

Device Problem Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/19/1959

Event Type  malfunction  

Event Description

The patient's port was accessed using a gripper micro/huber needle without difficulty.When the rn attempted to retract the inner needle so only the blunt tip needle would be in place, the inner needle was unable to be retracted.The clinician attempted to retract the needle and was also unable to retract it.The port was deaccessed and was reaccessed using a new needle, which functioned properly.

• Brand Name: DELTEC GRIPPER MICRO
• Type of Device: HUBER NEEDLE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; st. paul MN 55112
• MDR Report Key: 6618420
• MDR Text Key: 77002422
• Report Number: MW5070203
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/25/2017

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: No Information
• Device Catalogue Number: 21-3277-24
• Device Lot Number: 35X991
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 111