MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH2000S-PC
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2023
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 event occurred on an unspecified date and involved a spinning spiros® closed male luer, purple cap where it was reported by the customer the device presents a defective screw thread ¿ does not lock, leading to disconnection.There was unknown patient involvement, unknown adverse events/human harm.
Additional Manufacturer Narrative
Received one used.List #ch2000s-pc, spinning spiros® closed male luer, purple cap; lot #4549845.The used ch2000s-pc spinning spiros was confirmed to have the spin feature activated confirming that it had disconnected from a mating device.No mating device was returned to evaluate with the used ch2000s-pc spinning spiros.There was no visible damage or anomalies observed and the spin feature met product performance expectations.The probable cause of the reported disconnect cannot be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.D9 device returned to manufacturer on 8/9/2023.
Event or Problem Description
Additional information received by the customer stating the incident was observed during the preparation for the pui (hospital pharmacy) before dispensing to the care service.No adverse events, no human harm, no delay in therapy, no blood loss, no physical defects observed before use.Drug used with this device: cyclophosphamide.No leakage noted.The incident was observed at the end of preparation.

• Brand Name: SPINNING SPIROS® CLOSED MALE LUER, PURPLE 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: 17406214
• Report Number: 9617594-2023-00444
• Device Sequence Number: 20605558
• Product Code: FPA
• UDI-Device Identifier: 00840619027568
• UDI-Public: (01)00840619027568(17)250101(10)4549845
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082806
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2023

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 Expiration Date: 01/01/2025
• Device Catalogue Number: CH2000S-PC
• Device Lot Number: 4549845
• 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: 07/18/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2020
• 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: CYCLOPHOSPHAMIDE, UNK MFR.
• Patient Sex: Unknown