MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® NASOGASTRIC SUMP TUBE; FILTERS FOR NG TUBE

Model Number	0046000
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
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 markings on the ng tube had rubbed off.Without the markings, the nursing staff could not determine where the ng tube was inserted, or where it should be located.Additionally, it was alleged that residue remained in the filters after use.
Event or Problem Description
It was reported that the markings on the ng tube had rubbed off.Without the markings, the nursing staff could not determine where the ng tube was inserted, or where it should be located.Additionally, it was alleged that residue remained in the filters after use.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "warnings: check vent lumen routinely for reflux.This indicates an obstructed main lumen.Failure to clear obstruction and clear prevent filter may cause gas and fluid build-up in stomach.This may lead to aspiration, which may result in aspiration pneumonia and other complications.Do not inject fluid through filter.This may result in blockage and leakage of filter.Instructions for anti-reflux filter.1.Firmly seat the tapered end of anti-reflux filter in blue air lumen vent of nasogastric tube.2.Insure 5-in-1 adapter is snugly inserted into suction lumen to prevent suction loss.3.If gastric reflux in vent lumen is observed, clear the obstruction in the main lumen by following your hospital's standard protocol.Attach syringe to luer fitting on anti-reflux filter and inject a minimum of 15cc of air to clear the blue air vent lumen of any gastric reflux.Do not inject fluid through filter.4.To cap nasogastric tube when tube is not connected to a suction source insert transport plug on anti-reflux filter housing into suction lumen of nasogastric tube.5.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." corrections: d1, d2, d4, d10, g5, h3.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE
• Common Device Name: FILTERS FOR NG TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8384423
• Report Number: 1018233-2019-01123
• Device Sequence Number: 1498528
• Product Code: BSS
• UDI-Device Identifier: 00801741052286
• UDI-Public: (01)00801741052286
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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 Expiration Date: 07/31/2023
• Device Model Number: 0046000
• Device Catalogue Number: 0042180
• Device Lot Number: NGCU2173
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 03/02/2019
• Supplement Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1