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

Catalog Number 0067010

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject product was received for evaluation.Visual evaluation found the battery pack was within the handle and the battery latch was noted to be broken off.The battery pack was received firmly within the device.A broken battery latch is not indicative of a manufactured condition and based on the use facility reporting that the batteries were changed during use, the damage battery latch most likely occurred due to customer handling.A review of the manufacturing records was performed and found that the lot was manufactured to specification.

Event Description

It was reported per the user facility that during use of the simpulse varicare, the device was leaking fluid at the connection point of where the tip attaches to the handle.It was reported that there was no damage to the device.It was reported that the device was only used with one patient and the batteries were changed during the time of use, towards the end of treatment.There was no patient injury reported.The subject product was returned and during visual inspection it was noted the battery case latch tab was broken and not returned with the product.

• Brand Name: SIMPULSE VARICARE SUCTION IRRIGATOR
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 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: anna smith ; 100 crossings blvd.; warwick, RI 02886 ; 4018258449
• MDR Report Key: 9363952
• MDR Text Key: 193065333
• Report Number: 1213643-2019-11449
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00801741065293
• UDI-Public: (01)00801741065293
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2021
• Device Catalogue Number: 0067010
• Device Lot Number: JUCYF194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Date Manufacturer Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2018
• 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