MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 15" (38 CM) APPX 5.2 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS¿, 3 CLAMPS (BLUE,; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3187
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.Additional reporter contact: (b)(6).
Event or Problem Description
The complaint/event involved a 15" (38 cm) appx 5.2 ml, bifuse add-on set w/bag spike, spiros¿, 3 clamps (blue, red, white), dry spike adapter that reportedly leaked an unspecified chemotherapy drug during an infusion.No concomitant device, no bleed back, no delay in critical therapy and no patient harm was associated with the complaint/event.
Event or Problem Description
The customer provided additional information on 29-apr-2024 as follows: there was no physical damage noted on the device and the location of the leakage was unknown.There was no unprotected chemotherapy exposure in this event.There was no patient or healthcare provider harm.The chemo spill was cleaned up using a spill kit per the facility's protocol.The mating device was an unspecified icu medical plum set.The set was replaced and therapy resumed.
Additional Manufacturer Narrative
The following items were provided by the customer for complaint investigation: one used list #unknown, infusion set; lot #unknown.One used list #ch3187, 15" (38 cm) appx 5.2 ml, bifuse add-on set w/bag spike, spiros¿, 3 clamps (blue, red, white), plug adapter; lot #13507206.-one used.List #unknown, norm-saline injection "otsuka" 0.9% 100 ml intravenous bag; lot #b4c75.Saline and chemotherapy residuals were noted in the used with list #ch3187 and mating devices.Leaking was observed where tubing and piercing pin connect.The returned set was leak tested per product specifications.The tubing did not appear to be concentrically sealed to the bond pocket.The bond integrity was tested and met functional specifications.Evaluation of the bond area revealed gaps in solvent coverage.The reported complaint of leakage can be confirmed due to the channel leak.The probable cause of the channel leak is due to a manual bonding error during the assembly process of manufacturing.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Additional/updated information can be found in b5 and d10.Corrected information can be found in d7a - single use device.

• Brand Name: 15" (38 CM) APPX 5.2 ML, BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS¿, 3 CLAMPS (BLUE,
• 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: 19348458
• Report Number: 9617594-2024-00628
• Device Sequence Number: 7298936
• Product Code: ONB
• UDI-Device Identifier: 00840619025335
• UDI-Public: (01)00840619025335(17)280101(10)13507206
• 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): 05/23/2024

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: CH3187
• Device Lot Number: 13507206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 05/19/2024
• Supplement Report FDA Received Date: 05/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED CHEMOTHERAPY, MFR UNK; UNSPECIFIED PLUM SET, MFR ICU MEDICAL
• Patient Sex: Unknown