MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® SUCTION CONNECTOR

Model Number	EN0066000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
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 customer were experienced difficulties in removing suction tubing from the nasogastric tube once it has been connected.It was also stated that they have had bile and the secretions came out of the antireflux valve end of the tube which was getting on patients and bedding.Customer asked is there some sort of positioning that they need to do to help with this problem.As per the additional information received via email on 07apr2022, customer stated that the enfit tubes did not have the prevent filter attached.Stated that it was the little disc shaped integral plug component at the end of the pigtail.Inquirer responded that the plug was just for when they were transporting the patient and not sure why the enfit version did not include it.Inquirer assumed that there was an engineering reason but could not say for sure.It should not have any impact on the issue.
Event or Problem Description
It was reported that the customer were experienced difficulties in removing suction tubing from the nasogastric tube once it has been connected.It was also stated that they have had bile and the secretions came out of the antireflux valve end of the tube which was getting on patients and bedding.Customer asked is there some sort of positioning that they need to do to help with this problem.As per the additional information received via email on 07apr2022, customer stated that the enfit tubes did not have the prevent filter attached.Stated that it was the little disc shaped integral plug component at the end of the pigtail.Inquirer responded that the plug was just for when they were transporting the patient and not sure why the enfit version did not include it.Inquirer assumed that there was an engineering reason but could not say for sure.It should not have any impact on the issue, however.
Additional Manufacturer Narrative
The reported event is inconclusive since the physical sample was not returned.It is unknown whether the device had met relevant specifications.It is unknown whether the product had cause the reported failure.Visual evaluation of the attached photo sample noted 1 opened (without original packaging) bard suction connector connected to suction lumen.Visual inspection noted no obvious visible defects.It is unknown if leaks occurred without the physical sample received.Further investigation cannot be conducted.A potential root cause for this failure mode could be ¿incorrect design of diameter at the end of the lumen (luer syringe) incorrect, non-uniform thickness at funnel end¿.However there is no evidence that suggest that that this is the cause of the event.The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: "for use with bd¿ enfit¿ nasogastric sump tube and enfit¿ lopez¿ valve if suction is desired: ¿ attach to suction lumen of enfit¿ nasogastric sump tube.¿ attach to side a of enfit¿ lopez¿ valve." corrections: g h11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was evaluated.

• Brand Name: BARD® SUCTION CONNECTOR
• Common Device Name: SUCTION CONNECTOR
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14220197
• Report Number: 1018233-2022-03062
• Device Sequence Number: 11810878
• Product Code: JOL
• UDI-Device Identifier: 00801741128707
• UDI-Public: (01)00801741128707
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 11/09/2022

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: EN0066000
• Device Catalogue Number: EN0066000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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