MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3034
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
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 5" (13 cm) bag spike adapter w/spiros¿ w/red cap, vented cap generated a leak during patient use.The reporter stated, ¿5fu leaks from the spiros at 46hr.¿ the event occurred during infusion.There was a concomitant drug with a concomitant device involved.There was no bleed back, with chemo, no biohazard, and an unknown user facility medwatch.The device was not reprocessed/resterilized.The sample is available for return.The quantity affected is 1.A sample photo is not available.There was patient involvement, no adverse event/ patient harm, and no delay in critical therapy.The healthcare provider informed that the liquid leaked from spiros but there was no unprotected chemo exposure to the patient and healthcare provider since the chemo leaked to the floor.There was no healthcare provider harm.
Additional Manufacturer Narrative
Received one (1) used.List #ch3034, 5" (13 cm) bag spike adapter w/spiros¿ w/red cap, vented cap; lot #13870275.One (1) used.List #unknown, plum burette set; lot #unknown.No visual damages or anomalies were observed.The sample was tested to procedure and a leak was observed at the connection of the tubing and the spiros.The probable cause of the leak is from an assembly error during assembly in ensenada.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 5" (13 CM) BAG SPIKE ADAPTER W/SPIROS¿ W/RED CAP, VENTED CAP
• 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: 20556856
• Report Number: 9617594-2024-01521
• Device Sequence Number: 8961761
• Product Code: ONB
• UDI-Device Identifier: 00840619024116
• UDI-Public: (01)00840619024116(17)290101(10)13870275
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2024

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: CH3034
• Device Lot Number: 13870275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 5FU, UNK MFR; CH-14, ICU MEDICAL
• Patient Sex: Unknown