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	04/05/2022
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.
Event or Problem Description
As reported, during an unknown procedure, the bard/davol endo-flo irrigator leaked irrigation fluid when connected to the luer-lock of the non-bard/davol metal handpiece.As reported, connector did not seal and it appeared "like the threads are of the wrong pattern".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: 14238065
• Report Number: 1213643-2022-00199
• Device Sequence Number: 5015693
• 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: 04/05/2022
• 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