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	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
It was reported that a clave¿ neutral connector device was found to break during patient use.The reporter stated "the tip of the microclave connector has broken off, interrupting infusion.This problem occurs since the product has changed; the blue part is made of a different material than before.The event happened during priming.No blood loss and no unprotected chemo exposure.There was a delay in critical therapy but no adverse event happened.No adverse operator consequences, no med/surg intervention required.The device(s) were not changed out/replaced to check if there were no further problems encountered.Involved device(s) is not available to be tested.The same lot of device samples are available.Mating device(s) available to be tested.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
A photo of the tip of the microclave connector that has broken off.One (1) used.List #011-c3300, clave¿ neutral connector; lot #13861345 was received and tested.The reported complaint of a broken microclave could be confirmed, the tip of the microclave was observed to be broken with some stress whitening marks.The probable cause of the broken microclave is unknown.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20186889
• Report Number: 9617594-2024-01284
• Device Sequence Number: 7003139
• Product Code: FPA
• UDI-Device Identifier: 00840619001421
• UDI-Public: (01)00840619001421(17)281201(10)13861345
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2024

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: 13861345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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
• Patient Sex: Unknown