MAUDE Adverse Event Report: HOLOGIC, INC. AQUILEX FLUID CONTROL SYSTEM; INSUFFLATOR, HYSTEROSCOPIC

Model Number AQL-110

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2019

Event Type  malfunction  

Event Description

Aquilex tubing leaking due to loose fit, removed and replaced.

• Brand Name: AQUILEX FLUID CONTROL SYSTEM
• Type of Device: INSUFFLATOR, HYSTEROSCOPIC
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr.; marlborough MA 01752
• MDR Report Key: 8439204
• MDR Text Key: 139418277
• Report Number: 8439204
• Device Sequence Number: 1
• Product Code: HIG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AQL-110
• Device Catalogue Number: AQL-110
• Device Lot Number: K18L302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16790 DA