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

Catalog Number 0057621

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The subject product was not returned for evaluation, as such we are unable to review for root cause determination.Based on not having the sample returned to evaluate, no conclusion can be made.A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to the specification.If/when additional information is provided, a supplemental emdr will be submitted.

Event Description

It was reported that during inspection at the hospital warehouse, an unknown particulate was observed inside the simpulse plus showerhead tip suction irrigator package.There was no patient involvement as the reported product issue was discovered during inspection.

• Brand Name: SIMPULSE PLUS SUCTION IRRIGATOR TIP
• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 10372998
• MDR Text Key: 202950108
• Report Number: 1213643-2020-07172
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00801741010415
• UDI-Public: (01)00801741010415
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0057621
• Device Lot Number: JUDUF033
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2019
• 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