MAUDE Adverse Event Report: ICU MEDICAL INC SPINNING SPIROS CONNECTOR

Model Number	20130-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Engineering testing and analysis cont.Engineering testing of the returned used spinning spiros connector recorded a leak was observed coming from the half seal.The spinning spiros was disassembled and the half seal removed and evaluated.The report documents the half seal damage was the cause of the leakage.This condition/component damage occurred during the mfg.Assembly process.Findings: engineering evaluations of the returned packaged 20130-01 devices recorded no non-conformances and or out of spec.Conditions.The leakage issue was confirmed with the returned "used" spinning spiros connector.The cause of the leakage was due to damages within the internal componentry (half seal).Detailed analysis of the involved component manufacturing and assembly processes which included equipment, inspections and work instructions was performed.Cont.Pg.3 other remarks.The team identified several improvements focusing on the press, test operations and welder station processing operational 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 leakage issue with use of one (1) 20130-01 spinning spiros connector.It was reported that " technician noticed drug (carboplatin) leaking from the spiros.A section of plastic seems to be missing altogether from the spiros upon visual inspection".There was no patient involvement or any reported adverse operator consequences.Device return: one (1) used 20130-01 spinning spiros connector attached to a 20ml bd syringe containing carboplatin and two packaged spinning spiros connectors lot#'s 16-884-sj and 16-885-sj.Visual inspection and analysis (pre and post decontamination) was performed.The results recorded no obvious visual abnormalities with the unused packaged devices.During decontamination pressure was applied to the syringe while the spinning spiros was not activated and leakage was observed to come from inside the device.Engineering testing and analysis: the two unused spinning spiros connectors were pressure leak tested per the applicable product specification.The results recorded no performance issues, leakages and or out of spec conditions.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: 19554761
• Report Number: 2025816-2014-00161
• Device Sequence Number: 6805865
• Product Code: FPA
• UDI-Device Identifier: 00840619023386
• UDI-Public: (01)00840619023386(17)170501(10)16-884-SJ
• 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): 03/11/2013

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: 05/01/2017
• Device Model Number: 20130-01
• Device Catalogue Number: 20130-01
• Device Lot Number: 16-884-SJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2013
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2014
• Initial Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2012
• 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: 20ML BD SYRINGE
• Patient Sex: Unknown