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

Model Number	EN0066000
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
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.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 device was not returned.
Event or Problem Description
It was reported that the customer wanted to know if there was any risk with restricted suction caused by debris clogging the smaller suction adapter on the nasogastric tubes.It was recommended to periodically stop suction, irrigate and then continue suctioning and was told that it had been a perceived risk that they have heard but not of anyone encountering it.Customer stated that they have filed at least one medsun report that week because of clogging issues that were occurring frequently and wanted to know all documented steps for resolving clogs that bd had explored.Per follow via phone 29march2023, customer states they are still having the issues and that it appears the issues occurs more during post op as patients may have blood clots that get stuck during irrigation.No additional medical interventions were reported.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "blocked during use material deposits of bio origin".The device was not returned for evaluation.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: "if suction is desired: attach to suction lumen of enfit¿ nasogastric sump tube.Attach to side a of enfit¿ lopez valve®".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 or Problem Description
It was reported that the customer wanted to know if there was any risk with restricted suction caused by debris clogging the smaller suction adapter on the nasogastric tubes.It was recommended to periodically stop suction, irrigate and then continue suctioning and was told that it had been a perceived risk that they have heard but not of anyone encountering it.Customer stated that they have filed at least one medsun report that week because of clogging issues that were occurring frequently and wanted to know all documented steps for resolving clogs that bd had explored.Per follow via phone 29march2023, customer states they are still having the issues and that it appears the issues occurs more during post op as patients may have blood clots that get stuck during irrigation.No additional medical interventions were reported.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16919228
• Report Number: 1018233-2023-03366
• Device Sequence Number: 6930296
• Product Code: JOL
• UDI-Device Identifier: 00801741128707
• UDI-Public: (01)00801741128707
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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: Health Professional
• Device Model Number: EN0066000
• Device Catalogue Number: EN0066000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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