MAUDE Adverse Event Report: WELCH ALLYN, INC. FLEXI PORT DISPOSIBLE B/P CUFF; BLOOD PRESSURE CUFF

Model Number 901044

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/03/2019

Event Type  malfunction  

Event Description

Blood pressure cuff has broken fittings on the end of the tube.Went to replace it and found more with broken ends.Fda safety report id # (b)(4).

• Brand Name: FLEXI PORT DISPOSIBLE B/P CUFF
• Type of Device: BLOOD PRESSURE CUFF
• Manufacturer (Section D): WELCH ALLYN, INC. ; skaneateles NY 13153
• MDR Report Key: 8974963
• MDR Text Key: 158638438
• Report Number: MW5089632
• Device Sequence Number: 1
• Product Code: DXQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 901044
• Device Catalogue Number: (01)00732094187335
• Device Lot Number: (10)18-101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1