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

Catalog Number 0037970

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 290294559
• Report Number: 1213643-2022-00199
• Device Sequence Number: 1
• Product Code: HET
• UDI-Device Identifier: 00801741065217
• UDI-Public: (01)00801741065217
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0037970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other