MAUDE Adverse Event Report: COVIDIEN 0.9% NORMAL SALINE FLUSH COVIDIEN; SALINE, VASCULAR ACCESS FLUSH

Lot Number 20K2344

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Recall on 10ml monoject normal saline flushes.Fda safety report id# (b)(4).

• Brand Name: 0.9% NORMAL SALINE FLUSH COVIDIEN
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 12407284
• MDR Text Key: 269870320
• Report Number: MW5103654
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 8881570121
• UDI-Public: 8881570121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/30/2021

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: 20K2344
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2021
• Type of Device Usage: N
• Patient Sequence Number: 1