MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® NASOGASTRIC SUMP TUBE AND PREVENT® FILTER AND LOPEZ VALVE® WITH ENFIT¿; NG TUBE PREVENT & LOPEZ ENFIT

Model Number	EN0056160
Medical Device Problem Code	Incorrect Measurement (1383)
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 sump tubes with enfit connection had a smaller internal diameter than the tubes they had previously received.The nurses have stated that they were having a hard time getting adequate suction due to the smaller size and as a result the tubes were getting clogged when there were large food particles and/or pill particles in the gastric contents.This was a common occurrence in the emergency department and for patient's going emergently to the operating room.
Event or Problem Description
It was reported that the sump tubes with enfit connection had a smaller internal diameter than the tubes they had previously received.The nurses have stated that they were having a hard time getting adequate suction due to the smaller size and as a result the tubes were getting clogged when there were large food particles and/or pill particles in the gastric contents.This was a common occurrence in the emergency department and for patient's going emergently to the operating room.
Additional Manufacturer Narrative
The reported event is inconclusive due to poor sample condition.The sample photos show three different angles of the enfit connector from the front and side.No noticeable defects were visible from the photos provided.A potential root cause for this reported failure could be "incorrect design of diameter at the end of the lumen (luer syringe) incorrect." 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: "1.Attach medication port side 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 sideport, 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." 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.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE AND PREVENT® FILTER AND LOPEZ VALVE® WITH ENFIT¿
• Common Device Name: NG TUBE PREVENT & LOPEZ ENFIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8467207
• Report Number: 1018233-2019-01629
• Device Sequence Number: 19248603
• Product Code: FEG
• UDI-Device Identifier: 00801741113864
• UDI-Public: (01)00801741113864
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K960176
• 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): 06/07/2019

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: EN0056160
• Device Catalogue Number: EN0056160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1