MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. BBRAUN ADDITV IV ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 0061696452

Device Problem Material Discolored (1170)

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

Event Date 02/13/2020

Event Type  malfunction  

Event Description

Upon preparing to spike a 250ml sterile iv bag with the bbraun additv iv administration set (15 drop / ml, with universal spike, backcheck valve, two injection sites, and spin-lock connector) i noticed some unusual brown discoloration on the tip of the spike just as i removed the cap to insert it.The package itself did not show any discoloration and the only area that was discolored was the tip.

• Brand Name: BBRAUN ADDITV IV ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.
• MDR Report Key: 9733865
• MDR Text Key: 180707370
• Report Number: MW5093147
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0061696452
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• 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