MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMO LOCK® VIAL SPIKE

Model Number	CL-80S
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used, list # cl-80s, chemolock¿ vial spike, 20mm; lot # unknown and one used, empty, azacitidine for injection 100mg/vial were received for testing and evaluation.As received, it was observed that the tip of the vial spike was bent.When the spike was removed from the rubber stopper, two small particulates were observed on the spike.One appeared to be part of the rubber stopper and the other was a metal particle from the metal cap of the vial.The bent spike was pushed into a new vial and due to the bent spike tip, the stopper was cored and a piece of rubber particulate was pushed into the new vial.The cause of the rubber stopper particulates entering the vial is due to a bent vial spike tip coring the vial stopper.The metal piece appears to have come from the metal cap of the vial where a grove was observed.The probable cause of the bent vial spike tip cannot be determined at this time.A dhr review was not completed due to the unknown lot numbers.
Event or Problem Description
The event involved a chemolock vial spike that during preparation of vidaza (azacitidine), particles were noted inside the vial.The customer stated that this "coring" is only noted with this medication.There was no patient involvement, no adverse event, and no medical and surgical intervention required.

• Brand Name: CHEMO LOCK® VIAL SPIKE
• Common Device Name: CHEMO LOCK® VIAL 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: 8024436
• Report Number: 9617594-2018-00151
• Device Sequence Number: 1640028
• Product Code: ONB
• UDI-Device Identifier: 00887709069596
• UDI-Public: 887709069596
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• 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): 09/06/2018

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: CL-80S
• Device Catalogue Number: CL-80S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AZACITIDINE FOR INJECTION 100MG/VIAL, MFR UNK