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

Catalog Number	B3300
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was requested to be returned- it has not been received.The investigation is pending.
Event or Problem Description
The event occurred on an unknown date involving a clave¿ neutral connector where the customer reported that it was difficult to thread and difficult to unthread, unable to get the blue clave off.The customer stated that the problem is using the bd insyte autoguard with the icu medical b3300.The leak was taking place right at the connection of both once twisted together.The customer also stated that it is very difficult to turn (twist) the b3300 into the autoguard threads and once in, it is almost impossible to remove it like it is stuck.There was unknown patient involvement but no adverse event.
Additional Manufacturer Narrative
No b3300 product samples, videos or photographs were returned for investigation.The dhr for possible lot # 14105415 was reviewed, and there were no non-conformances found that would have contributed to the reported complaint.The complaint cannot be confirmed, without the return of the used sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.Corrected information can be found in h6, medical device problem codes and component codes.

• 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: 20848332
• Report Number: 9617594-2024-01732
• Device Sequence Number: 12825980
• Product Code: FPA
• UDI-Device Identifier: 00840619045593
• UDI-Public: 00840619045593
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100434
• 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): 01/27/2025

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: B3300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: INSYTE AUTOGUARD, BD MFR
• Patient Sex: Unknown