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

Catalog Number 21-3256-24

Device Problem Retraction Problem (1536)

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

Event Date 04/04/2018

Event Type  malfunction  

Event Description

Rn accessed the patient's port-a-cath using the gripper micro needle, was able to aspirate and flush.Upon trying to retract the needle, the device would not retract.Entire device was removed and patient had to be accessed again.

• Brand Name: GRIPPER MICRO DELTEC
• Type of Device: BLUNT HUBER NEEDLE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 1265 grey fox road; st. paul MN 55112
• MDR Report Key: 7406481
• MDR Text Key: 104733951
• Report Number: 7406481
• Device Sequence Number: 1
• Product Code: LJT
• 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: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 12/20/2022
• Device Catalogue Number: 21-3256-24
• Device Lot Number: 37X1747
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2018
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 2 YR
• Patient Weight: 14