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

Catalog Number 0056160

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.

Event Description

It was reported that a crack found when inserting nasogastric tube into patient.They opened a second tube and the same issue.Pulled one with a different lot number and no problem.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.Visual evaluation of the returned sample noted four unopened (without original packaging), nasogastric sump tube.Visual inspection of the sample noted the four nasogastric pump tube was observed and no crack or holes noted.No root cause could be found because the reported event was unconfirmed.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.As the reported event is unconfirmed a labeling review is not required.Correction: d, h h11: section a through f - the information provided by bd represents all 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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that a crack found when inserting nasogastric tube into patient.They opened a second tube and the same issue.Pulled one with a different lot number and no problem.

• Brand Name: NASOGASTRIC SUMP TUBE WITH PREVENT® ANTI-REFLUX FILTER AND LOPEZ VALVE®
• Type of Device: NASOGASTRIC TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18265881
• MDR Text Key: 329720791
• Report Number: 1018233-2023-08729
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 00801741052392
• UDI-Public: (01)00801741052392
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0056160
• Device Lot Number: NGHR0116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other