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

Catalog Number	011-NC100
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to return for evaluation.It has not been received.
Event or Problem Description
The event involved a neutron® at the end of the infusion of the lavage of the chemotherapy, a wet part of the bandage was noted and some drops were falling from the neutron, leaking laterally.A small side crack was noted on the device.The device was in use for 48 hours prior to the event.There was no adverse event, no delay in critical therapy, no blood loss and there was no medical or surgical intervention required.
Additional Manufacturer Narrative
H10 - no product samples, videos, or photographs were returned for investigation.The device history review (dhr) was reviewed and there were no non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.Additional information can be found in section d10.
Additional Manufacturer Narrative
Date returned to mfg - july 9, 2020 a single used 011-nc100 neutron was returned and when visually examined there were no cracks, visual anomalies, or damage observed.No mating devices were returned to evaluate with the used 011-nc100 neutron.Though there were clear droplets inside the used 011-nc100 neutron between the body and seal outside the fluid path a probable cause of those droplets cannot be determined.

• Brand Name: NEUTRON
• Common Device Name: 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
• MDR Report Key: 10013703
• Report Number: 9617594-2020-00124
• Device Sequence Number: 2089172
• Product Code: FPA
• UDI-Device Identifier: 00840619054076
• UDI-Public: (01)00840619054076(17)240801(10)4191064
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K100434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2024
• Device Catalogue Number: 011-NC100
• Device Lot Number: 4191064
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 05/27/2020; 07/20/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 06/17/2020; 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPEC CHEMOTHERAPY