MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76 CM) APPX 3.2 ML, 20 DROP ADMIN SET W/INTEGRATED CLAVE® DRIP CHAMBER, SPI; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	20124-01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a 30" (76 cm) appx 3.2 ml, 20 drop admin set w/integrated clave® drip chamber, spiros®, bag hanger.Just below the drip chamber, the tubing of the device was reported as cracked and split which resulted in a chemotherapy (carpboplatin) spill.The product was in use for zero hours and the event happened during priming.A code brown was called.Chemotherapy spilled on a staff member and onto the floor of the chemo suite.There was patient involvement and delay in therapy.There was no adverse event reported and there was no harmed.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device, a probable cause is unable to be determined.If additional information or if a device becomes available, supplemental vigilance report(s) will be submitted at that time.

• Brand Name: 30" (76 CM) APPX 3.2 ML, 20 DROP ADMIN SET W/INTEGRATED CLAVE® DRIP CHAMBER, SPI
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18307734
• Report Number: 9617594-2023-01114
• Device Sequence Number: 6151814
• Product Code: FPA
• UDI-Device Identifier: 00840619023331
• UDI-Public: (01)00840619023331(17)280701(10)13712875
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2023

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 Catalogue Number: 20124-01
• Device Lot Number: 13712875
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2023
• 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: CARPBOPLATIN, MFR UNK
• Patient Sex: Unknown