MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 63" (160 CM) APPX 10.6 ML, EXT SET, PUR W/CHECK VALVE, 2 CLAVE¿, SPIROS¿ W/RED C; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH3967
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a 63" (160 cm) appx 10.6 ml, ext set, pur w/check valve, 2 clave¿, spiros¿ w/red cap where it was reported that the spiros broke off the patient end when connecting.There was unknown patient involvement and unknown human harm.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
Device returned to manufacturer on 5/17/2024 received one used ch3967 ext set, pur w/check valve, 2 clave, spiros for inspection.The spiros was observed to be broken from the spinning luer.Examination of the weld area showed gaps in the welding.The reported complaint can be confirmed.The probable cause is due to an error during automated assembly.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
Additional information received stating the chemotherapy infusion nurse stated that the faulty tubing has approx.10ml of chemotherapy (etoposide) inside.

• Brand Name: 63" (160 CM) APPX 10.6 ML, EXT SET, PUR W/CHECK VALVE, 2 CLAVE¿, SPIROS¿ W/RED C
• 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: 19274757
• Report Number: 9617594-2024-00560
• Device Sequence Number: 15036750
• Product Code: FPA
• UDI-Device Identifier: 00887709121720
• UDI-Public: (01)00887709121720(17)290201(10)13915449
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K081361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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: CH3967
• Device Lot Number: 13915449
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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: ETOPOSIDE, UNK MFR
• Patient Sex: Unknown