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

Model Number CL-80S

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 08/22/2018

Event Type  malfunction  

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 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
• Type of Device: 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
• Manufacturer (Section G): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• Manufacturer Contact: patricia sharpe-gregg, bsn, rn ; 600 n. field drive, 2n; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 8024436
• MDR Text Key: 125674243
• Report Number: 9617594-2018-00151
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00887709069596
• UDI-Public: 887709069596
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AZACITIDINE FOR INJECTION 100MG/VIAL, MFR UNK