MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. BRAUN 1 L NS NON-DEHP BAG; SET, I.V. FLUID TRANSFER

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Chemical Exposure (2570)

Event Date 04/17/2020

Event Type  malfunction  

Event Description

The 1 litter ns bag of braun brand (none dehp) containing less than 20ml of chemo medications (etoposide, doxorubicin and vincristine) split open on the floor causing a major spill on the floor and chemo nurse.Fda safety report id #: (b)(4).

• Brand Name: BRAUN 1 L NS NON-DEHP BAG
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 9987044
• MDR Text Key: 188864687
• Report Number: MW5094215
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/18/2020

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Weight: 128