MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/0.2 MICRON FILTER, CLAVE® CLEAR, CLAMP, ROTATING LUER; STOPCOCK, IV SET

Catalog Number	MC9013
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	07/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 14" ext set w/0.2 micron filter, clave¿ clear, clamp, rotating luer where it was reported that when the patient got up to go to the washroom, she noticed the iv line was disconnected from the filter line while paclitaxel was infusing.The medication spilled on patient's hands, the rn¿s hands, and on the floor.The pump stopped and was cleaned using a chemotherapy spill kit and according to alberta health service (ahs) policy.The patient came into direct contact with cytotoxic drug and infusion was delayed while spill was cleaned up impact of the incident.Invasive procedure is not provided or not applicable.Additionally, it was reported that the filter tubing was completely disconnected from the iv tubing when the staff noticed it.It is unknown how long into infusion the leak occurred.No report of a blood loss or bleed back.There was patient involvement and no apparent harm-reached patient/person, inconvenient.
Additional Manufacturer Narrative
The complaint of disconnection / loose connection on item mc9013 could not be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history report (dhr) for lot was reviewed and no non conformities were found that would have led the reported complaint.Additional contact: (b)(4).

• Brand Name: 14" EXT SET W/0.2 MICRON FILTER, CLAVE® CLEAR, CLAMP, ROTATING LUER
• Common Device Name: STOPCOCK, IV SET
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17611134
• Report Number: 9617594-2023-00595
• Device Sequence Number: 7421506
• Product Code: FMG
• UDI-Device Identifier: 00887709039391
• UDI-Public: (01)00887709039391(17)280401(10)13611650
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2023

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: MC9013
• Device Lot Number: 13611650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• 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: PACLITAXEL, MFR UNK
• Patient Sex: Female