MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of ascrs0127 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the huber's needle (cannula for puncture reservoir 0.90x25mm 20g) after use, the safety device did not allow to be triggered.No other information provided.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 1 IN
• 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: 8615650
• MDR Text Key: 145364619
• Report Number: 3006260740-2019-01397
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066221
• UDI-Public: (01)00801741066221
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/16/2019

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
• Device Expiration Date: 03/28/2021
• Device Model Number: N/A
• Device Catalogue Number: LH-0032
• Device Lot Number: ASCRS0127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2018
• 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