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

Catalog Number	0067570
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject product was received for evaluation with the battery pack installed within the handle of the device.The latch tab used to secure the device¿s battery pack within the device handle was noted to be broken and was found in the packaging returned with the device.Even with the broken latch tab, the battery pack was noted to remain fully seated and remained firmly within the handle and when activated, the subject product functioned as intended.There was no report of the component breakage by the user.This is the first reported complaint for the subject lot of 1000 units manufactured in may of 2017.A dhr review was conducted and no discrepancies or anomalies were found during the manufacture of the subject lot.Based on the sample evaluation, we are unable to determine how and when the battery latch tab became broken.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Event or Problem Description
During the sample evaluation of a simpulse solo irrigator reported as not functioning, the latch on the battery case was found broken off.The latch was returned with the sample.

• Brand Name: SIMPULSE SOLO 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: 6801766
• Report Number: 1213643-2017-00511
• Device Sequence Number: 11022770
• Product Code: FQH
• UDI-Device Identifier: 00801741010125
• UDI-Public: (01)00801741010125(17)200328(10)JUBRF275
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K942886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/17/2017

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: 03/28/2020
• Device Catalogue Number: 0067570
• Device Lot Number: JUBRF275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2017
• Initial Report FDA Received Date: 08/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1