MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 ENDO-FLO IRRIGATOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0037970
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the bard/davol endo-flo irrigator leaks fluid when used with a reusable metal non-bard/davol trumpet valve instrument, and there is no leaking when the endo-flo irrigator is being used with disposable plastic instruments.A photo was provided that confirms a fluid leak at the luer lock location where the reusable metal non-bard/davol trumpet valve instrument connects to the irrigation tubing of the bard/davol endo-flo.Neither the bard/davol endo-flo, or the reusable metal non-bard/davol trumpet valve instrument has been provided for evaluation; therefore the potential cause of the incompatibility/leaking between the two devices could not be determined.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Not returned.
Event or Problem Description
As reported, during a gallbladder repair procedure on (b)(6) 2022, the bard/davol endo-flo irrigator leaked irrigation fluid when used with a reusable non-bard/davol trumpet valve.There was no reported patient injury.Reporter stated "the tubing does not leak with disposable instruments.It only leaks with the metal instrument.It does not leak when connecting to a plastic connector.When attaching the tubing to the metal irrigation instrument, there is significant leakage at the connector.".

• Brand Name: ENDO-FLO IRRIGATOR
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 14234435
• Report Number: 1213643-2022-00197
• Device Sequence Number: 4406235
• Product Code: HET
• UDI-Device Identifier: 00801741065217
• UDI-Public: (01)00801741065217
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K902722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/13/2022

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 Catalogue Number: 0037970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 04/28/2022
• 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