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	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject product was received for evaluation.Visual evaluation found the battery pack was within the handle and the latch was noted to be broken off.The battery pack was firmly within the device.The spike cap and lock pin were still inserted in the device, indicating the device had not been set up for use.No information was provided regarding the condition of the device when it was received by the user and the original packaging was not returned with the product.It is possible the damage to the device occurred due to shipping and handling; however, this cannot be determined at this time.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to specification.A review of the subject lot number found this to be the first reported complaint for the (b)(4) units manufactured in december of 2018.
Event or Problem Description
It was reported that the lower part of the simpulse solo handle was damaged after opening the package.There was no patient involvement reported.

• 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: 9480343
• Report Number: 1213643-2019-12192
• Device Sequence Number: 19566776
• Product Code: FQH
• UDI-Device Identifier: 00801741010125
• UDI-Public: (01)00801741010125
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K942886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2021
• Device Catalogue Number: 0067570
• Device Lot Number: JUCZF012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1