MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ONCOLOGY KIT W/SPINNING SPIROS®, C-CLIP, RED CAP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH3581
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The complaint involved a oncology kit w/spinning spiros®, c-clip, red cap that was reported to leak chemotherapy at the connection of the mating device's male luer to the spiros during a patient infusion.The report states that on one primary set with the spiros and collar attached, the spiros came off of the primary set.There was no adverse event or harm and no delay in therapy.
Additional Manufacturer Narrative
The following items were returned by the customer for complaint investigation: -one used list #ch3581, oncology kit w/spinning spiros®, c-clip, red cap; lot #13414750.-one used manufacturer unknown, extension set w/ y-connectors; lot #unknown.-one used manufacturer unknown, 150ml burette; lot #unknown.-one used list #unknown, bag spike extension w/ calve side port; lot #unknown.-one used list #unknown.Intravia container 150ml bag; lot #dr22i21024.The returned set was primed per procedure and no leaks were identified between the connection of the bd male luer to spiro.The male luer of the mating device and the female luer of the spiro were measured and found to be within specification.The complaint of leaks could not be confirmed based on the physical sample evaluation.The device history record (dhr) was reviewed and no relevant commodities, discrepancies or anomalies were found that might lead the condition reported by customer.D9 - date returned to mfg: 13oct2023.

• Brand Name: ONCOLOGY KIT W/SPINNING SPIROS®, C-CLIP, RED CAP
• 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: 17595961
• Report Number: 9617594-2023-00581
• Device Sequence Number: 6369989
• Product Code: FPA
• UDI-Device Identifier: 00887709079243
• UDI-Public: (01)00887709079243(17)271101(10)13414750
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2023

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: CH3581
• Device Lot Number: 13414750
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 11/08/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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: UNSPECIFIED CHEMOTHERAPY, MFR UNK; UNSPECIFIED MATING DEVICE W/ MALE LUER, MFR BD
• Patient Sex: Unknown