MAUDE Adverse Event Report: FRESENIUS KABI / FENWAL INTERNATIONAL, INC. FENWAL SAMPLING SITE COUPLER; SUPPLIES, BLOOD-BANK

Model Number 4C2405F

Device Problem Material Separation (1562)

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

Event Date 12/09/2021

Event Type  malfunction  

Event Description

Rubber tip for entrance into sampling site couple fell off when needle was injected into coupler, creating an open coupler with no closure.Fda safety report id # (b)(4).

• Brand Name: FENWAL SAMPLING SITE COUPLER
• Type of Device: SUPPLIES, BLOOD-BANK
• Manufacturer (Section D): FRESENIUS KABI / FENWAL INTERNATIONAL, INC.
• MDR Report Key: 13011596
• MDR Text Key: 282384336
• Report Number: MW5106054
• Device Sequence Number: 1
• Product Code: KSS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4C2405F
• Device Lot Number: GD900969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1