MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® NASOGASTRIC SUMP TUBE WITH PREVENT; NASOGATRIC TUBE

Model Number 0046160

Device Problems Flushing Problem (1252); Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the nasogastric tubes would not flush.When an attempt was made to flush the tube, it came out of the vent port.No harm reached the patient, other than having to place another ng/og tube.

Event Description

It was reported that the nasogastric tubes would not flush.When an attempt was made to flush the tube, it came out of the vent port.No harm reached the patient, other than having to place another ng/og tube.

Manufacturer Narrative

The reported event was confirmed.The device did not meet specifications.The product was used for treatment purposes.Visual evaluation of the returned sample noted one opened (without original packaging), nasogastric tube.Visual inspection of the sample noted no obvious visible defects.The clear tube was flushed with methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water).The solution was able to flow out of the eyelets.A leak was noted from a small hole where the blue pigtail tube was inserted into the dual lumen tube.This was out of specification which stated, "leak test.No leaks are allowed between the lumens of nasogastric tube." although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿mix of solvent.¿ 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: ¿instructions for prevent® anti-refl ux filter 1.Firmly seat the tapered end of anti-refl ux filter in blue air lumen vent of nasogastric tube.2.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.3.To cap nasogastric tube when tube is not connected to a suction source insert transport plug on anti-refl ux filter housing into suction lumen of nasogastric tube.Instructions for lopez valve (when included): 1.Attach medication port cap to side ¿c¿.2.Turn valve to position one.3.Attach suction tube to side ¿a¿ and push together firmly.4.For reorder codes 0056120, 0056140, 0056160, 0056180: if connection to a male connector is desired, attach universal adaptor to side a.Insert male connector into adaptor, 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." correction: e2 (initial reporter health professional).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.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE WITH PREVENT
• Type of Device: NASOGATRIC TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9197905
• MDR Text Key: 184758733
• Report Number: 1018233-2019-06541
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 00801741052323
• UDI-Public: (01)00801741052323
• Combination Product (y/n): N
• PMA/PMN Number: K960176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0046160
• Device Catalogue Number: 0046160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1