MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. APPX 0.91 ML, GRADUATED ADAPTER WITH CLAVE®; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3900
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional contact: (b)(6).The device was discarded and not available for investigation.However, a sample photo was provided for evaluation.The investigation is pending.
Event or Problem Description
The event involved an appx 0.91 ml, graduated adapter with clave® where an unspecified chemo drug leaked from the foley catheter during infusion.There was patient involvement, but no patient harm and no delay in critical therapy.
Additional Manufacturer Narrative
No product samples were returned for investigation, however, a photograph was returned showing a ch3900 graduated adapter with clave connected to the female luer of a non-icu medical mating device and a confirmed leak at the connection point of the two components.Without return of the affected samples a probable cause cannot be determined.The device history report (dhr) for lot 13515399 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

• Brand Name: APPX 0.91 ML, GRADUATED ADAPTER WITH CLAVE®
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• 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: 17886055
• Report Number: 9617594-2023-00807
• Device Sequence Number: 6966068
• Product Code: ONB
• UDI-Device Identifier: 00840619025748
• UDI-Public: (01)00840619025748(17)280101(10)13515399
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K173477
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

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: CH3900
• Device Lot Number: 13515399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2023
• 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: FOLEY CATHETER, MFR UNK; UNSPECIFIED CHEMO, MFR UNK
• Patient Sex: Unknown