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

Model Number	0042160
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
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 nasogastric tube was leaking.Per additional information received via phone on 21-dec-2022, it was reported that the customer had used the connection that was not indicated to bd.It was also stated that they had been hooking it up to a feeding administration set for continuous feed which was not bd ng tubes.Representative reviewed the indications that were short were short from feed and suggested that the customer needed a connection which allows for the suction tubing.
Additional Manufacturer Narrative
Per additional information received, bd has determined that this mdr event is not reportable.
Event or Problem Description
It was reported that the nasogastric tube was leaking.Per additional information received via phone on 21dec2022, it was reported that the customer had used the connection that was not indicated to bd.It was also stated that they had been hooking it up to a feeding administration set for continuous feed which was not bd ng tubes.Representative reviewed the indications that were short were short from feed and suggested that the customer needed a connection which allows for the suction tubing.

• Brand Name: BARD® NASOGASTRIC SUMP TUBE
• Common Device Name: NASOGASTRIC SUMP 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: 16068640
• Report Number: 1018233-2022-09985
• Device Sequence Number: 12330929
• Product Code: BSS
• UDI-Device Identifier: 00801741052262
• UDI-Public: (01)00801741052262
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2023

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: Lay User/Patient
• Device Expiration Date: 07/01/2026
• Device Model Number: 0042160
• Device Catalogue Number: 0042160
• Device Lot Number: NGFZ3795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown