MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS® CLOSED MALE LUER, RED CAP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	20130-01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date in (b)(6) or (b)(6) of 2021 involving a spinning spiros® closed male luer, red cap that leaked while infusing toptecan and mycophenolate.The reporter mentioned that there were no obvious defects noted and the problem was noticed when the rn was hanging the medication on the secondary line and noticed that there was a leakage.The rn was wearing ppe but patients were not protected as they do not wear ppe.There was patient involvement but no adverse event and no harm.This is the first of three events.
Additional Manufacturer Narrative
No product samples, videos, or photographs were provided for investigation.The device history review (dhr) was reviewed and there were no relevant 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.

• Brand Name: SPINNING SPIROS® CLOSED MALE LUER, RED CAP
• 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
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 13101496
• Report Number: 9617594-2021-00315
• Device Sequence Number: 20007710
• Product Code: FPA
• UDI-Device Identifier: 00840619023386
• UDI-Public: (01)00840619023386(17)260801(10)5579719
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K082806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2021

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: 08/01/2026
• Device Model Number: 20130-01
• Device Catalogue Number: 20130-01
• Device Lot Number: 5579719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MYCOPHENOLATE, MFR UNK; TOPTECAN, MFR UNK
• Patient Sex: Unknown