MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE CLEAR, CHEMOLOCK PORT, SPIROS; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number	CL3931
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	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not been received.
Event or Problem Description
The event involved a 8.5" (22 cm) appx 1.0 ml, ext set w/microclave® clear, chemolock¿ port, spiros® w/red cap, clamp that at 7:30-7:45am leaked busulfan on the patient.It was reported that the patient called the nurse and it was found that the patient was covered with chemo, but no visible affects were observed.The patient's chemo treatment was discontinued for the day.A spill kit was used for clean up.There was patient involvement, and although there was a report of a delay in therapy, there was no adverse event and no one harmed as a result of the reported event.
Additional Manufacturer Narrative
One used list#: cl3931, 8.5" (22 cm) appx 1.0 ml, ext set w/microclave¿ clear, chemolock¿ port, spiros¿ w/red cap, clamp (lot#: 5118644), one used unknown pump set, and one used baxter container 250 ml 0.9% sodium chloride were received on february 8, 2021 and visually inspected.As received, no damage or anomalies were identified.The set was leak tested and leakage occurred from the chemolock port/y-connector bond.Further examination of the bond under a microscope revealed the male luer post of the chemolock port was not fully inserted into the y-connector bond pocket.The reported complaint can be confirmed.The probable cause of the inadequate luer insertion and subsequent leak is due to an error during the manual assembly process.A device history review for lot#: 5118644 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: 8.5" (22 CM) APPX 1.0 ML, EXT SET W/MICROCLAVE CLEAR, CHEMOLOCK PORT, SPIROS
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• 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: 11333737
• Report Number: 9617594-2021-00044
• Device Sequence Number: 823292
• Product Code: ONB
• UDI-Device Identifier: 00887709077201
• UDI-Public: (01)00887709077201(17)251201(10)5118644
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2021

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: 12/01/2025
• Device Model Number: CL3931
• Device Catalogue Number: CL3931
• Device Lot Number: 5118644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 03/08/2021
• 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: BUSULFAN, MFR UNK.