MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. HYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number 0026870

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 03/13/2016

Event Type  Injury  

Manufacturer Narrative

As reported, the event occurred after use of the hydrosurg irrigator.A review of the hydrosurg product family found this to be the first reported complaint of a laceration.The spike is designed to be sharp to perform it's function of spiking iv bags.While the product was not returned, for evaluation, there was no indication given that the product did not meet specification.The ifu for the hydrosurg irrigator states "after use, this product is a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws (u.S.A.) and regulations." 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.: not returned for evaluation.

Event Description

Information as reported by the user facility: it was reported that the housekeeper encountered the hydrosurg irrigator in the trash when pulling out the trash bag from waste bin.When pulling out the plastic bag, the irrigation spike poked through the plastic bag and pierced the palm of the housekeeper.This occurred after use of the device during the cleaning process in the or with the disposed device.This incident was reported to the or manager the following day and proper precautions were taken.The housekeeper was tested and given an (b)(6).Contact indicates the housekeeper refused further medical treatment (prophylaxis) but will be tested, per hospital protocol, for 6 months.The housekeeper had a fairly deep cut, however, this did not require any sutures and the housekeeper is healing.

Manufacturer Narrative

The original outcome attributed to the adverse event reported was incorrect.This supplemental is being submitted to correct that error.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.

• Brand Name: HYDRO-SURG PLUS LAPAROSCOPIC IRRIGATOR
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: anna smith ; 100 crossings blvd.; warwick, RI 02886 ; 4018258449
• MDR Report Key: 6584284
• MDR Text Key: 75763521
• Report Number: 1213643-2017-00320
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00801741000362
• UDI-Public: (01)00801741000362
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 0026870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Required Intervention