MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT, DRY SPIKE

Model Number	13814-01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returning for evaluation.A device history review (dhr) was not completed due to the unknown lot number.The reported complaint cannot be confirmed without the returned sample.
Event or Problem Description
The event involved a customer report of a chemotherapy spill of vincristine when the spike of the chemoclave bag spike came out of the dry port during "circum priming".It was reported that the facility practices "circum priming" where instead of using normal saline for priming (since it takes a while for the chemo drug to reach to a patient), a chemo drug was used.The dry spike is hooked to the chemo tubing and automatically starts priming.Once done, the chemo tubing is hooked to a patient.This event happened after the pharmacy spiked the bag and added the drug to the bag.The nurse was getting the bag set up to infuse when the spike came off causing the spill.There was no patient involvement, no adverse event, no medical or surgical intervention provided and no delay in critical therapy.

• Brand Name: CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT, DRY SPIKE
• Common Device Name: CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT, DRY SPIKE
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, 22790 ; MX 22790
• MDR Report Key: 8055992
• Report Number: 9617594-2018-00156
• Device Sequence Number: 19246040
• Product Code: FPA
• UDI-Device Identifier: 00887709065383
• UDI-Public: 00887709065383
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K081361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2018

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
• Operator of Device: Health Professional
• Device Model Number: 13814-01
• Device Catalogue Number: 13814-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1