MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. NEUTRON; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 011-NC100

Device Problem Fluid/Blood Leak (1250)

Patient Problems Skin Inflammation (2443); Chemical Exposure (2570)

Event Date 05/01/2020

Event Type  malfunction  

Manufacturer Narrative

The lot number of the device that was in use is unknown.The customer identified two possible lot numbers (plots).The possible lot numbers are 4059306 (expiry date 04/01/2024 , mfr date (b)(6) 2019), and 4014010 (expiry date 03/01/2024, mfr date (b)(6) 2019).Initial reporter facility address (b)(4).The device was discarded.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.If additional information becomes available a supplemental report will be submitted.

Event Description

The event occurred on an unspecified date that involved a neutron connector that disconnected from the huber needle during an infusion of cisplatin resulting in the patient being exposed to chemotherapy on the left side of the back causing mild secondary dermatitis.The patient was cleaned and put in observation.The spill code was activated after the patient was mobilized to minimize exposure.The patient was hospitalized for a chemotherapy cycle.

• Brand Name: NEUTRON
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 10320804
• MDR Text Key: 219565547
• Report Number: 9617594-2020-00266
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K100434
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 011-NC100
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1