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

Model Number	0056000
Medical Device Problem Code	Fluid/Blood Leak (1250)
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.
Event or Problem Description
It was reported that the lopez valve leaked when connected to the feeding tube.
Event or Problem Description
It was reported that the lopez valve leaked when connected to the feeding tube.
Additional Manufacturer Narrative
The reported event could not be confirmed.It was unknown whether the device met specifications since no sample was returned for evaluation.The product was used for treatment purposes.A potential failure mode could be ¿leaks¿ with a potential root cause of "dimensions not designed correctly".The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿adult lopez valve® non-sterile/single patient use - do not sterilize.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.For use with nasogastric sump tubes.Reorder number: 0056000.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¿.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.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: 1-800-526-4455).U.S.Patent nos: 4790832; 4895562.Bard is a registered trademark of c.R.Bard, inc.Or an affiliate.Lopez valve is a registered trademark of (b)(6) and distributed by c.R.Bard, inc.".Correction: d10, h3.H11:section a through f - 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 was not returned.

• 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: 9866240
• Report Number: 1018233-2020-02021
• Device Sequence Number: 16738619
• Product Code: KNT
• UDI-Device Identifier: 00801741052361
• UDI-Public: (01)00801741052361
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/27/2020

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: 0056000
• Device Catalogue Number: 0056000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1