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

Model Number N/A

Device Problem Fail-Safe Did Not Operate (4046)

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

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.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.

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.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty advancing the safety mechanism is confirmed to be supplier related.One 22 ga x 0.75 in safestep infusion set was returned for investigation.The safety mechanism had not been activated.An attempt to activate the safety mechanism revealed excessive resistance to advance the safety base.Additional force was required to successfully activate the safety mechanism.A microscopic observation revealed adhesive between the metal sleeve and needle shaft.The adhesive is likely to have been introduced during the manufacturing process; therefore, the complaint is confirmed to be supplier related.Corrective actions have been implemented by the supplier.

• 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
• MDR Report Key: 8745968
• MDR Text Key: 149651494
• Report Number: 3006260740-2019-01826
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066160
• UDI-Public: (01)00801741066160
• Combination Product (y/n): N
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 07/16/2019

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
• Event Location: Hospital
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1