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

Catalog Number	0067600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/09/2018
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 broken and was found taped to the handle of the device.Even with the broken latch tab, the battery pack was noted to remain fully seated and remained firmly within the handle.A broken battery latch tab was not initially reported by the user facility and the batteries had been removed prior to returning the device for evaluation.Based on the available information and sample evaluation, we are unable to definitively determine how and when the battery latch tab became broken.A dhr review was conducted and no discrepancies or anomalies were found during the manufacture of the subject lot.
Event or Problem Description
As reported by the user facility: during the sample evaluation of a returned simpulse solo irrigator reported as not priming and a slow/sluggish stream, the latch on the battery case was found broken off.The latch was returned with the sample.It was noted by the customer on the outer packing of the sample "came from package broken battery pack".The batteries had been removed from the battery pack.The device does not appear to have been used.Hospital contact was not able to provide any details.

• 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: 8069816
• Report Number: 1213643-2018-03992
• Device Sequence Number: 16691762
• Product Code: FQH
• UDI-Device Identifier: 00801741010149
• UDI-Public: (01)00801741010149
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2018

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: 12/28/2020
• Device Catalogue Number: 0067600
• Device Lot Number: JUCNF484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1