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

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable fmea documents, and labeling.Based on a review of this information, the following was concluded: the complaint of a leak is inconclusive due to poor sample condition.One photo sample of a safestep infusion set was returned for investigation.The needle housing and a section of the extension tubing are visible in the photo.Blood appears to be present within the extension tubing.Damage on the device could not be clearly seen.Since evidence of a leak was not observed in the photo sample provided, the complaint is inconclusive due to poor sample condition.A lot history review (lhr) of asdns0044 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the patent went home with the safestep needle was in for seven days.It is facility policy to change in seven days.During the flushing of the needle, the nurse noticed the leak between the tubing and the needle connection.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 1 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8533665
• Report Number: 3006260740-2019-01127
• Device Sequence Number: 19443892
• Product Code: FPA
• UDI-Device Identifier: 00801741066221
• UDI-Public: (01)00801741066221
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/19/2019

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LH-0032
• Device Lot Number: ASDNS0044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1