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 Patient Involvement (2645)

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

The subject product was returned for evaluation.Functional evaluation of the sample found no fluid leak identified from the endo-flo tubing or pump housing or at the luer-lock connection.The endo-flo was found to irrigate as intended.Evaluation of the sample could not reproduce the reported event.No manufacturing anomalies were found and review of manufacturing records indicate product was manufactured to specification.Based on the sample evaluation and investigation performed, the reported event was unconfirmed.To date, this is the only reported complaint for this manufacturing lot of 360 units released for distribution in december, 2019.Sample evaluated.

Event Description

As reported on (b)(6) 2021, the bard/davol endo-flo irrigator leaked saline near the diaphragm during flushing.As reported, perfused water was flowing at the time of preparation for use, and water leaked from the vicinity of the diaphragm, and use was stopped at that point.There was no reported patient involvement.

• 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: 11324060
• MDR Text Key: 231789534
• Report Number: 1213643-2021-20027
• Device Sequence Number: 1
• Product Code: HET
• UDI-Device Identifier: 00801741065217
• UDI-Public: (01)00801741065217
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K902722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2022
• Device Catalogue Number: 0037970
• Device Lot Number: JUDY0297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Date Manufacturer Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2019
• 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