MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of ascyf015 showed no other similar product complaint(s) from this lot number.(b)(4).
Event or Problem Description
It was reported via medwatch, "patient accessed with 22 gauge 1 inch port, noted leaking from device." no other information provided.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of ascyf015 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via medwatch, "patient accessed with 22 gauge 1 inch port, noted leaking from device." no other information provided.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G 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: 8997640
• Report Number: 3006260740-2019-02639
• Device Sequence Number: 2352156
• Product Code: FPA
• UDI-Device Identifier: 00801741066184
• UDI-Public: (01)00801741066184
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2020

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-0030
• Device Lot Number: ASCYF015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/19/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2243072-06/03/2020-006-R
• Patient Sequence Number: 1