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

Catalog Number	EN0056000
Medical Device Problem Code	Leak/Splash (1354)
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 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.The device was not returned.
Event or Problem Description
It was reported that there was leakage from the suction port of the lopez valve.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use was found adequate and states the following: "caution: read all instructions prior to use.Non-sterile/single patient use - do not sterilize.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.For use with nasogastric sump tubes en0056000 lopez valve® instructions for lopez valve 1.Attach medication port cap to side ¿c¿.2.Turn valve to position one and attach ng tube to side ¿b¿.3.Attach suction tube to side ¿a¿ if suction is desired.4.To administer medication, remove cap.Attach syringe to side port, push and twist until tight and turn valve to position four.Flush valve per facility protocol following administration.5.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." the device was not returned.
Event or Problem Description
It was reported that there was leakage from the suction port of the lopez valve.Per follow up with the complainant via voicemail on oct 1 2018 the lopez valve was connected to a feeding tube at the time of the leak.

• Brand Name: BARD® LOPEZ VALVE® WITH ENFIT¿
• Common Device Name: ADULT LOPEZ VALVE ENFIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7917969
• Report Number: 1018233-2018-04470
• Device Sequence Number: 1526709
• Product Code: KNT
• UDI-Device Identifier: 00801741113901
• UDI-Public: (01)00801741113901
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K915171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2018

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: Health Professional
• Device Catalogue Number: EN0056000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 09/28/2018
• Supplement Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1