MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CLAVE¿ NEUTRAL CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	011-C3300
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information can be found in b5.Corrected information can be found in e1.
Event or Problem Description
The report reflects one of three same/similar incidents.
Event or Problem Description
The complaint/event involved a clave¿ neutral connector that reportedly popped off easily when connected to an unspecified extension set during an infusion.The customer indicated that the device felt more oily.There was no concomitant drug or chemotherapy involved, no bleedback, no adverse event/patient harm and no delay in critical therapy.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.Section e additional contact: (b)(6).
Additional Manufacturer Narrative
Three device samples were returned for evaluation.As received, a needless was connected to the used sample, however, no additional damage or anomalies were observed.Each of the samples were leak-tested and no internal/external leaks were observed after the test.The male luers were measured and were found to be within specifications.The customer's complaint of disconnection cannot be confirmed or replicated.The device history record could not be reviewed because no lot number was identified.D9 - date returned to mfg: 05jun2024.

• Brand Name: CLAVE¿ NEUTRAL CONNECTOR
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19462944
• Report Number: 9617594-2024-00725
• Device Sequence Number: 17805626
• Product Code: FPA
• UDI-Device Identifier: 00840619001421
• UDI-Public: (01)00840619001421
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K970855
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2024

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: 011-C3300
• Device Lot Number: UNKNOWN
• 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: 05/22/2024
• Supplement Date Received by Manufacturer: 05/22/2024; 07/01/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 06/04/2024; 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 EXTENSION SET, MFR UNK
• Patient Sex: Unknown