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 Patient Involvement (2645)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11324060
• Report Number: 1213643-2021-20027
• Device Sequence Number: 3283940
• Product Code: HET
• UDI-Device Identifier: 00801741065217
• UDI-Public: (01)00801741065217
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K902722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2021

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 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other