MAUDE Adverse Event Report: BARD ACCESS SYSTEMS INC. WHIN SAFE; SAFETY HUBER NEEDLE SET

Lot Number	REBP0165
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Upon accessing the powerport, air noted while attempting to aspirate blood for lab tests.Lots of bubbles mixed with blood obtained.Attempted to obtain blood from other hub site met with same result.Needle immediately removed and new needle inserted.Blood obtained with no air noted.

• Brand Name: WHIN SAFE
• Common Device Name: SAFETY HUBER NEEDLE SET
• Manufacturer (Section D): BARD ACCESS SYSTEMS INC.; bethlehem PA 18018
• MDR Report Key: 7049141
• Report Number: MW5073475
• Device Sequence Number: 1471975
• Product Code: FPA
• UDI-Device Identifier: 00801741044922
• UDI-Public: 00801741044922
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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 Expiration Date: 01/31/2020
• Device Lot Number: REBP0165
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Weight: 79