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

Catalog Number	0067010
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject product was discarded and not returned by the user facility.Without having the sample returned to evaluate, a root cause or probable root cause cannot be determined at this time.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This mdr represents the second simpulse varicare device used on the patient.The first device was submitted on mdr 1213643-2020-04400.Device discarded by user facility.
Event or Problem Description
It was reported that there was corrosion noted on the battery compartment of the simpulse varicare device.The corrosion was observed when they went to use the irrigator and it would not work properly.There was no contact of the device with the patient or the sterile field.The device was being used for closed pulse irrigation, and it was unable to complete any procedures because it did not work on initial attempt.There was no reported patient injury.

• Brand Name: SIMPULSE VARICARE SUCTION IRRIGATOR
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 10029906
• Report Number: 1213643-2020-04463
• Device Sequence Number: 17114154
• Product Code: FQH
• UDI-Device Identifier: 00801741065293
• UDI-Public: (01)00801741065293
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K942886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2020

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: 04/28/2022
• Device Catalogue Number: 0067010
• Device Lot Number: JUDSF308
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 05/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR