MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 18 CM (7") APPX 0.43 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE¿ CLEAR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	011-MC33001
Medical Device Problem Codes	Difficult to Open or Close (2921); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.A lot number has been provided.Pending device history lot review.
Event or Problem Description
It was reported that an 18 cm (7") appx 0.43 ml, pressure infusion (400psig) ext set w/microclave¿ clear, purple clamp, rotating luer, was found to be occluded during patient use.It was stated that the extension had a purple clamp that made it difficult to attach after washing.It was informed that at the hospital they have a post-infusion washing protocol, with the right hand they connect a syringe with saline solution and perform the push/stop technique.At the same time, with your left hand, clamp the extension tube and then disconnect the saline syringe.The customer reports that the purple large slide clamp is very hard and makes it difficult to hold correctly with one hand.They believe the extensions may be poorly secured and have detected an increase in airway occlusion.It was also reported that the problem did not only happen with this batch, but they also detected other times that the clamp was very hard.There was a non-used sister sample available for evaluation.According to the form, the product is not contaminated, does not present a biological risk or contains a chemotherapeutic agent.The product was used with an unspecified medication and had not been reprocessed or re-sterilized before use.It was also informed that the issue happened with all received units of this product.The event occurred during patient use, so, there was patient involvement, however, there was no delay in therapy, adverse event or harm to anyone as result of this event.
Additional Manufacturer Narrative
D9 - date returned to mfg: 1/16/2025.Received one new.List #011-mc33001, ext set, pressure (400psig) w/clave for inspection.No defects or anomalies noted.Per product specifications, one hand was used to clamp by placing a finger on each side of the clamp and pushing on the back of the clamp with the thumb.There was difficulty clamping the tubing with one hand.The set was measured and met dimensional specifications.The clamps and tubing set were tested per product specification.When the clamps were unclamped, there was no issue in flow.While the tubing was clamped the clamp prevented flow.The complaint of difficulty to clamp can be confirmed.The probable cause is unknown.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 18 CM (7") APPX 0.43 ML, PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE¿ CLEAR
• 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: 21153820
• Report Number: 9617594-2025-00096
• Device Sequence Number: 18425508
• Product Code: FPA
• UDI-Device Identifier: 00840619057442
• UDI-Public: (01)00840619057442(17)290501(10)14026236
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K100576
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2025

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: 011-MC33001
• Device Lot Number: 14026236
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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: SYRINGE WITH SALINE SOLUTION, UNK MFR.
• Patient Sex: Unknown