MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 SIMPULSE SOLO SUCTION IRRIGATOR; LAVAGE, JET

Catalog Number	0067590
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the bard/davol simpulse solo leaked irrigation fluid at the trigger end of the device.The subject device was returned for evaluation.Evaluation of the sample finds that with the showerhead tip still affixed a small amount of fluid was found to be leaking from device.The tip was removed and visual inspected find no anomalies.The o-ring is present and in good condition.The tip was reinserted into the unit and fluid was gravity flowed through the system.No fluid leak could be reproduced at this time.Based on the sample evaluation and investigation performed, the most probable root cause is the showerhead tip not being fully inserted while in use.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.
Event or Problem Description
As reported, during a procedure on (b)(6) 2021, the bard/davol simpulse solo leaked irrigation fluid at the trigger end of the device.There was no reported patient injury and no medical intervention was required.

• Brand Name: SIMPULSE SOLO SUCTION IRRIGATOR
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 12531837
• Report Number: 1213643-2021-20340
• Device Sequence Number: 13806762
• Product Code: FQH
• UDI-Device Identifier: 00801741010132
• UDI-Public: (01)00801741010132
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K942886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2021

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: 12/28/2023
• Device Catalogue Number: 0067590
• Device Lot Number: JUEZ1495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 09/27/2021
• 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