MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	12514-01
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has begun, but is not yet completed.Upon completion a supplemental mdr report will be submitted.
Event or Problem Description
An event that occurred on an unknown date involved a 7" (18 cm) appx 0.45 ml, pressure infusion (400psig) ext set w/ microclave¿ clear, purple clamp, rotating luer that had free flow of infusion.It was reported that, nurses stated they have a lot of trouble clamping the line due to the stiff tubing and have to use two hands to push the slide clamp.They also stated once clamped, it didn¿t fully close the line and fluid was still able to get through.Many times nurses aren¿t following clamping protocol due to how difficult it is to clamp the line.There was unknown patient involvement and unknown patient impact.
Additional Manufacturer Narrative
Investigation summary: received three (3) new 12514-01 pressure infusion extension sets 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 on each of the sets.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 reported complaint of leakage could not be replicated or confirmed.The complaint of difficulty to clamp can be confirmed.The probable cause is unknown.The dhr for lot 13921593 was reviewed and no relevant non conformities were found that would have led to the reported complaint.

• Brand Name: 7" (18 CM) APPX 0.45 ML, PRESSURE INFUSION (400PSIG) EXT SET W/ MICROCLAVE®
• 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: 19590271
• Report Number: 9617594-2024-00805
• Device Sequence Number: 19709527
• Product Code: FPA
• UDI-Device Identifier: 00887709044470
• UDI-Public: (01)00887709044470(17)290301(10)13921593
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K100576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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: 12514-01
• Device Lot Number: 13921593
• Was Device Available for Evaluation?: Yes
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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
• Patient Sex: Unknown