MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 15 CM (6") APPX 0.28 ML, J-LOOP W/BONDED CLAVE®, LUER SLIP; STOPCOCK, I.V. SET

Catalog Number	IA-CU9014B
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one used ia-cu9014b j-loop w/ bonded clave for inspection.As received, a fold over stick down was observed on the clave.The reported complaint can be confirmed.The probable cause is due to access at an angled entry.The dfu states: when connecting a medical device to the female luer connector, do so slowly and straight.The conduit inside the connector may be damaged, resulting in fluid leakage and contamination, or occlusion.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The event involved a 15 cm (6") appx 0.28 ml, j-loop w/bonded clave, luer slip where it was reported the customer connected a saline filled syringe to collect blood sample and then flush with saline.The saline solution leaked and overflowed from where the calve connector and syringe were connected.Medical device used in combination with the complaint product was a 2.5ml syringe.There was blood exposure outside the complaint product.The device was replaced.The event occurred at a hospital.A pre-use check was conducted in accordance with the statement in ifu.There was no damage to the product observed and no manipulation to the product was done.The event occurred during the use of the product and no adverse event was reported.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.

• Brand Name: 15 CM (6") APPX 0.28 ML, J-LOOP W/BONDED CLAVE®, LUER SLIP
• Common Device Name: STOPCOCK, I.V. SET
• 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: 19536094
• Report Number: 9617594-2024-00763
• Device Sequence Number: 12368495
• Product Code: FMG
• UDI-Device Identifier: 00887709012707
• UDI-Public: (01)00887709012707(17)280801(10)13730773
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K964435
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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: IA-CU9014B
• Device Lot Number: 13730773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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: 2.5 ML SYRINGE, UNK MFR; SALINE, UNK MFR
• Patient Sex: Unknown