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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.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 leaked between the syringe and the spiros luer lock when the nurse was getting ready to administer a doxorubicin infusion.It was reported that diluted chemo touched the skin of the patient¿s forearm when the spiros came disconnected from the syringe.The area was washed immediately (skin remained intact) and the chemo spill was cleaned up per facility protocol.The tubing was set up with intravenous push (ivp) administered at lowest hub of the unknown tubing set that was infusing normal saline to gravity.The set up and drug was replaced and administered successfully without further incident.There were no holes, cuts, tears or any defects noted.There was patient involvement and no adverse event reported.

• 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: 10623275
• Report Number: 9617594-2020-00427
• Device Sequence Number: 3735182
• 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: 09/16/2020
• Initial Report FDA Received Date: 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1