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

Catalog Number	0056000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 red cap "pops off" of the lopez valve when the patient moves or coughs.
Additional Manufacturer Narrative
Received 1 lopez valve with the original packaging opened.The reported event was unconfirmed.During the visual inspection it was observed that the red cap was connected to the valve.Per the dimensional evaluation, the device was found within specification.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: "caution: read all instructions prior to use.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Instructions for lopez valve.Attach medication port cap to side ¿c¿.Turn valve to position one and attach ng tube to side ¿b¿.Push together firmly.For suction, attach suction tube to side ¿a¿ and push together firmly.If connection to a male connector is desired, attach universal adapter to side ¿a¿.Insert male connector into adapter, and push together firmly.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.Return valve to position one when complete to avoid leakage.Caution: federal (u.S.A.) laws restricts this device to sale by or on the order of a physician.Labeling issue date: 1/00.In the event 3 years have elapsed between this date and product use, the user should contact bard to see if additional product information is available (telephone number: (b)(6)." (b)(4).
Event or Problem Description
It was reported that the red cap "pops off" of the lopez valve when the patient moves or coughs.

• Brand Name: BARD® LOPEZ VALVE® WITH ENFIT
• Common Device Name: LOPEZ VALVE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6988129
• Report Number: 1018233-2017-05560
• Device Sequence Number: 1292416
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

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: 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: 10/28/2017
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1