MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFETY HUBER 20G X 0.75IN WITH NF VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	585112
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of (b)(4) showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported in (b)(6) 2020 there was an issue with a 0.75" needle that had been externally leaking with air bubbles noted in line.

• Brand Name: SAFETY HUBER 20G X 0.75IN WITH NF VALVE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11426089
• Report Number: 3006260740-2021-00693
• Device Sequence Number: 4014882
• Product Code: FPA
• UDI-Device Identifier: 00801741044922
• UDI-Public: (01)00801741044922
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K071846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2021

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: 585112
• Device Catalogue Number: 585112
• Device Lot Number: REDP0338
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/05/2021
• 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