MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS CLOSED MALE LUER, 10 UNITS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH2000S-10
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product samples, videos, or photographs were returned for investigation, however, the dhr was reviewed and a molding irregularity was observed that can lead to internal leakage.The probable cause of the leaking spiros is due to a molding anomaly on the sealing surface of the poppet sub-component.The list and lot number of the device was identified as part of a voluntary recall.Icu medical is notifying affected customers via a letter requiring removal of the affected products from the market.
Event or Problem Description
The event involved a spinning spiros® closed male luer, 10 units that the customer reported a leak of doxorubicin.A bolus dose of doxorubicin was being administered at the lowest hub of the normal saline tubing that was running to gravity.The spiros came disconnected from the syringe, diluted chemotherapy touched the patient's forearm, and the area was washed immediately.There was patient involvement, however, no delay in delivery due to the event and no report of adverse event.

• Brand Name: SPINNING SPIROS CLOSED MALE LUER, 10 UNITS
• 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: 10572526
• Report Number: 9617594-2020-00409
• Device Sequence Number: 11080188
• Product Code: FPA
• UDI-Device Identifier: 00840619033910
• UDI-Public: (01)00840619033910(17)250301(10)4757614
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K082806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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: 03/01/2025
• Device Catalogue Number: CH2000S-10
• Device Lot Number: 4757614
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/23/2020
• 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: DOXORUBICIN, MFR UNK; UNSPECIFIED SYRINGE, MFR UNK; UNSPECIFIED TUBING SET