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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	09/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two 011-nc100 neutron connectors were returned for investigation without seal stick downs or evidence the white/clear 'stopper' at the tip had fallen out.One was returned outside the package with some slit propagation tearing on the top surface of the seal and with blood residual between the body and the seal.The other was returned inside an open package.There were no visual anomalies noted.No mating devices were returned for evaluation with the two 011-nc100 neutron connectors.Subsequent, pressure leak testing showed the two 011-nc100 neutron connectors to meet pressure leak expectations outlined in the product performance specification.The complaint of leaking/dripping was unable to be replicated.A dhr for lot# 4142493 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.
Event or Problem Description
It was reported that, on an unknown date, the nurse noticed blood leaking/dripping out of picc at a fast rate.It was reported that the patient had just had iv medications given through the lumen a few minutes earlier.The nursing staff clamped the lumen and changed the neutron, which was reported to have stopped the flow of blood.Upon further investigation, by staff, it was alleged that the neutron was damaged with the white/clear 'stopper' at the tip having fallen out.There was no harm to the patient reported.No additional information is available.

• 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; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 9182437
• Report Number: 9617594-2019-00339
• Device Sequence Number: 14101169
• Product Code: FPA
• UDI-Device Identifier: 00840619054076
• UDI-Public: (01)00840619054076(17)240601(10)4142493
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/16/2019

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: 06/01/2024
• Device Catalogue Number: 011-NC100
• Device Lot Number: 4142493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2019
• Initial Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1