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

Catalog Number	0057570
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject product was returned for evaluation.Visual evaluation of the subject product found a hair inside of the sealed product packaging.The hair was removed and had characteristics indicating the foreign body is likely a human hair.Root cause is identified as manufacturing related, as the hair would have been introduced at the time of packaging.This is the first report of a foreign material for the subject lot of (b)(4) units manufactured in june of 2019.
Event or Problem Description
It was reported that before opening the simpulse varicare irrigator package, foreign material like hair was noted inside of the sealed package.The package was not opened and another device was used to complete the procedure.There was no patient involvement.

• Brand Name: SIMPULSE PLUS 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: 9527235
• Report Number: 1213643-2019-12529
• Device Sequence Number: 398948
• Product Code: FQH
• UDI-Device Identifier: 00801741065255
• UDI-Public: (01)00801741065255
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K830386
• 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): 12/27/2019

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: 04/28/2022
• Device Catalogue Number: 0057570
• Device Lot Number: JUDSF439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 12/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1