MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ADULT LOPEZ VALVE®

Catalog Number	0056000
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.
Event or Problem Description
It was reported that the (b)(6) valve would not stay closed.
Event or Problem Description
It was reported that the lopez valve would not stay closed.
Additional Manufacturer Narrative
The reported event was unconfirmed.Received one used lopez valve for evaluation.During the visual inspection, it was observed that the handle was in the off position and the red cap was assembled in the lopez valve (cg50084).The cap and lopez valve were inspected for deformities, damages and cracks and no defects were observed that could have contributed to the defect reported.Per the functional evaluation, the handle was turned to off position and it was observed that the handle closed correctly.Water was used to test the lopez valve, closing and opening the valve and it functioned as intended.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "1.Attach medication port cap to side ¿c¿.2.Turn valve to position one and attach ng tube to side ¿b¿.Push together firmly.3.For suction, attach suction tube to side ¿a¿ and push together firmly.4.If connection to a male connector is desired, attach universal adapter to side ¿a¿.Insert male connector into adapter, and push together firmly.5.To administer medication, remove and store medication port cap in valve turn handle.Attach syringe to sideport, push and twist until tight and turn valve to position four.Flush valve per facility protocol following administration.6.Return valve to position one when complete to avoid leakage.Fluid path is open when arrow indicators are aligned with luer connections.Off handle indicates closed port." (b)(4).

• Brand Name: ADULT LOPEZ VALVE®
• Common Device Name: LOPEZ VALVE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7129973
• Report Number: 1018233-2017-06388
• Device Sequence Number: 18855373
• Product Code: KNT
• UDI-Device Identifier: 00801741052361
• UDI-Public: (01)00801741052361
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K915171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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: Lay User/Patient
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 0056000
• Device Lot Number: NGBP0409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 02/17/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1