MAUDE Adverse Event Report: AQUABILITI AQUASTAT SFR STERILE FIELD READY FLUSH SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Lot Number KH04631

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 10/17/2019

Event Type  malfunction  

Event Description

Saline flush syringe end sheared off as it was being screwed on to the luer lock cap of a picc.

• Brand Name: AQUASTAT SFR STERILE FIELD READY FLUSH SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): AQUABILITI
• MDR Report Key: 9219278
• MDR Text Key: 163571913
• Report Number: MW5090532
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/18/2019

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
• Device Operator: No Information
• Device Lot Number: KH04631
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2019
• Patient Sequence Number: 1
• Patient Age: 93 YR
• Patient Weight: 77