MAUDE Adverse Event Report: ICU MEDICAL INC SPINNING SPIROS CONNECTOR

Model Number	20130-01
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional engineering analysis of the 20130-01 spinning spiros was performed.The spinning spiros was tested per the applicable product specification.The results recorded a internal leak.Under microscopic observation it was found that the device o-ring component was missing.This condition caused the internal leakage.Findings: engineering evaluation of the returned devices confirmed the 20130-01 spinning spiros was manufactured incorrectly.Detailed analysis of the involved component manufacturing and assembly processes which included equipment, inspections and work instructions was performed.The team identified several improvements focusing on the press, test operations and welder station processing sequences.The automated assembly process now has a sensor that 100% verifies the presence and proper placement of the componentry (o-ring on the female luer).The work flows were modified, additional detailed assembly instructions were implemented and affected employee training was performed.
Event or Problem Description
Complaint received reporting occlusion/extraction difficulties with set-up consisting of one (1) 20130-01 spinning spiros; syringe; vial adaptor.It was reported that " technician was unable to withdraw drug from vial adapter.The syringe-spiros combination seems to just draw air, and not allow drug to be pulled up through the syringe".There was no patient involvement or any reported adverse operator consequences.Device return: one used 20130-01 spinning spiros attached to a 10ml bd syringe; genie vial adaptor attached to vial of dacogen.Engineering testing and analysis of the returned set-up was performed.The results recorded no functional or performance issues with the returned genie vial adaptor.Initial evaluation of the 10ml syringe - mated to the 20130-01 spinning spiros documents that when accessed would only draw air, thus confirming the reported product issue.Cont.Section h.10.

• Brand Name: SPINNING SPIROS CONNECTOR
• Common Device Name: CONNECTOR
• Manufacturer (Section D): ICU MEDICAL INC; 600 n. field dr; lake forest IL 60045
• Manufacturer (Section G): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa., 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 4455 atherton dr.; salt lake city, UT 84123
• MDR Report Key: 19554760
• Report Number: 2025816-2014-00162
• Device Sequence Number: 12463925
• Product Code: FPA
• UDI-Device Identifier: 00840619023386
• UDI-Public: (01)00840619023386(17)171201(10)23-064-Y1
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/08/2013

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: 12/01/2017
• Device Model Number: 20130-01
• Device Catalogue Number: 20130-01
• Device Lot Number: 23-064-Y1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2013
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2014
• 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: 10ML BD SYRINGE' GENIE VIAL ADAPTOR.; DACOGEN VIAL.
• Patient Sex: Unknown