MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problems Positioning Problem (3009); Fail-Safe Did Not Operate (4046)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: sample evaluation, patient severity, complaint and lot history, applicable previous investigation(s), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a stuck safety mechanism was confirmed and the cause was determined to be use related.The product returned for evaluation was a 22ga x ¾¿ safestep infusion set.The safety mechanism of the device was pulled away from the needle base by 3-4mm.The safety mechanism was confirmed to be stuck in position, being slightly pulled away from the needle base.Gross visual evaluation of the device, with a specific focus on the safety mechanism, found that the needle shaft was slightly bent at the location of the stuck mechanism.Microscopic examination of the region found that the metal collar of the safety mechanism was in direct contact of the bend joint.Further microscopic examination found no evidence of other potential contributing factors.The safety mechanism was then forced open and inspected additionally for potential causes of the bent shaft.It was seen that the bend would have occurred at the distal edge of the safety mechanism plate.This type of event can occur if the patient is not accessed by pushing directly downwards with the infusion set.No potential manufacture contributing factor was observed.A lot history review (lhr) of asbxs0227 showed six other similar product complaint(s) from this lot number.

Event Description

It was reported that during removal of the safestep form the port body, the base did not move down and the safety mechanism didn¿t work.There was no reported patient injury.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 8745844
• MDR Text Key: 149812587
• Report Number: 3006260740-2019-01824
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066160
• UDI-Public: (01)00801741066160
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• 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-0029
• Device Lot Number: ASBXS0227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2017
• 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