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

Catalog Number 0067590

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/31/2021

Event Type  malfunction  

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 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
• Type of Device: LAVAGE, JET
• 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 ; san geronimo industrial park; lot #1, road #3, km 79.7; humacao, PR 00791 ; 7876565500
• MDR Report Key: 12531837
• MDR Text Key: 273302776
• Report Number: 1213643-2021-20340
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00801741010132
• UDI-Public: (01)00801741010132
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K942886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2021
• 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