CHEMOLOCK BAG SPIKE - A CSTD COMPONENT CL-3955

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-06 for CHEMOLOCK BAG SPIKE - A CSTD COMPONENT CL-3955 manufactured by Icu Medical, Inc..

Event Text Entries

[178348761] Cstd dropped out of chemotherapy infusion bag as the nurse was hanging the bag to start infusion. Both the patient and nurse were exposed. The infusion of chemotherapy (carboplatin) was closed using the icu medical cstd, chemolock until the cl-3955 fell out of the bag resulting in approximately 50ml of hazardous solution falling on the nurse, patient, patient? S chair and the floor where the nurse was standing. The nurse was able to insert the spike back into the bag to stop flow. The bag/tubing was contained in chemo zip lock bag then returned to the pharmacy for black bucket bulk chemo waste disposal. The pharmacy compounded a second bag for treatment of the patient. After a spill during training ((b)(6) 2019) the icu medical representatives supplied clips prevent bag spike from falling out of bbraun non-pvc bags and later a second bag clip for the hospira/icu medical button type of infusion bags. They did not mention a 3rd type of bag clip for the type of bag involved in our spill after the spill occurred, they could have prevented this exposure/spill if they had let us know. We use the 1st and 2nd type of bag clips routinely on those bags but we had no knowledge of the possibly of icu medical ndc 0990-7984-37 failing to retain the chemolock cl-3955 bag spike. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5092828
• MDR Report Key: 9681767
• Date Received: 2020-02-06
• Date of Report: 2020-02-04
• Date of Event: 2020-02-03
• Date Added to Maude: 2020-02-07
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PHARMACIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CHEMOLOCK BAG SPIKE - A CSTD COMPONENT
• Generic Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTRUCTION AND TRANSFER SYSTEM
• Product Code: ONB
• Date Received: 2020-02-06
• Model Number: CL-3955
• Lot Number: 4344340
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ICU MEDICAL, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-06