MAUDE Adverse Event Report: HOLOGIC, INC. FLUENT FLUID MANAGEMENT SYSTEM; HYSTEROSCOPIC INSUFFLATOR

Model Number FLT-112S

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.Lot number of the disposable device not provided by the complainant, therefore the expiration date is not known.Lot number of the second disposable device was not provided by the complainant, therefore the expiration date and date of manufacture are unknown.The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed.Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known.

Event Description

It was reported that during a procedure involving the fluent fluid management system the disposable set was not properly connected to the collection bag.This resulted in the disconnection of the collection bag and 200-300ml of saline ran onto the floor until the issue was observed.A second disposable kit was opened and set up on the fluent system.This second disposable was also installed incorrectly with a kink present in the outflow tubing, this resulted in a pressure buildup in the sample collection canister.The tissue samples fell onto the floor and were lost.There was no injury or impact reported to the patient.

• Brand Name: FLUENT FLUID MANAGEMENT SYSTEM
• Type of Device: HYSTEROSCOPIC INSUFFLATOR
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: david ramsay ; 250 campus drive; marlborough, MA 01752 ; 5082638713
• MDR Report Key: 10515487
• MDR Text Key: 206519683
• Report Number: 1222780-2020-00118
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/12/2020

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
• Device Operator: Health Professional
• Device Model Number: FLT-112S
• Device Catalogue Number: FLT-112S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/10/2020
• 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