MAUDE Adverse Event Report: B. BRAUN MEDICAL INC NORMAL SALINE BAG; CONTAINER, I.V

Model Number E8000

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problems Burning Sensation (2146); Chemical Exposure (2570)

Event Type  No Answer Provided  

Event Description

Safety concern; chemo spill; summary: during the infusion of a 1000 ml bag of etoposide, doxorubicin, vincristine (vesicants), the spike came out of the bag and spilled all over the nurse.Background: the bag was spiked using a short primary tubing and connected to an alaris pump.Patient ambulated to the bathroom, as rn waited for the patient, rn noticed that there was a bubble in the iv tubing and lightly flicked the tubing to get rid of the bubble; instead the iv tubing detached from the bag and as a result there was a chemo spill.Result: the nurse felt as if her skin was burning, similar to a sunburn.She did not see a physician, it did not blister.Patient was not harmed or spilled on.Spilled chemo bag was disposed appropriately and new chemo bag was given/hung.Product information: the model/ref number of the tubing is 10015862 (carefusion).The model/ref number of the normal saline bag is e8000, ndc (b)(4) (bbraun).Assessment: due to the stiffness of the port of the bag and the unsecured nature of the connection between the port of the iv tubing, our institution will switch products to prevent other chemo spills.Relevant materials provided: image.(b)(6).(b)(4).

• Brand Name: NORMAL SALINE BAG
• Type of Device: CONTAINER, I.V
• Manufacturer (Section D): B. BRAUN MEDICAL INC
• MDR Report Key: 8339474
• MDR Text Key: 137132751
• Report Number: MW5084054
• Device Sequence Number: 2
• Product Code: KPE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 02/13/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: E8000
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1