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

Catalog Number 0067010

Device Problems Break (1069); Crack (1135)

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 device had been physically damaged.A crack was identified in the housing and the two halves of the housing were slightly separated from the weld.The battery pack was within the handle and the latch was noted to be broken off.The battery pack was firmly within the device.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Originally the customer did not report any damage to the simpulse devices; however, after follow up with the customer, it was noted that one simpulse devices had been cracked in use.The customer contact reported that there is a possibility that these devices may be reused and the batteries may be removed and/or replaced by the user facilities.It is most likely the damage to the device occurred due to customer handling.

Event Description

It was reported per the user facility that during use of the simpulse varicare irrigator, the device would not irrigate.There was no patient injury reported.The subject product was returned and during visual inspection it was noted that 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: 9194253
• MDR Text Key: 162792763
• Report Number: 1213643-2019-09969
• 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: 10/15/2019

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: 10/28/2021
• Device Catalogue Number: 0067010
• Device Lot Number: JUCYF194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/15/2019
• 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