MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 19G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Activation Problem (4042)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that when the needle was removed from the implantable venous device, the needle did not retract.Remained stuck on the dressing is when the nurse wanted to take it off that she pricked herself.

• Brand Name: SAFESTEP HUBER NEEDLE SET 19G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer Contact: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 10258892
• MDR Text Key: 198369145
• Report Number: 3006260740-2020-02390
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066245
• UDI-Public: (01)00801741066245
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LH-0033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/19/2020
• 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