MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 15 CM (6") SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING LUER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 011-MC33094

Device Problem No Flow (2991)

Patient Problem Pain (1994)

Event Date 10/28/2023

Event Type  malfunction  

Manufacturer Narrative

No product samples, videos, or photographs were provided for investigation.The device history review (dhr) was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.E1 initial reporter address: (b)(6).

Event Description

The event involved a 15 cm (6") smallbore ext set w/microclave® clear, clamp, rotating luer.The customer stated after the smallbore extension set was placed, many nurses noticed a strong abnormal resistance when injecting contrast products.A higher flow rate higher than 3ml/sec was needed.The customer decided to place another smallbore extension of the same reference, but the problem persists.They tested the access without the anti-return valve, and at that moment, no more resistance problem.The department had to put back a venous access to the patient causing a new intrusion.The status of the product at the time of the event is during infusion.Clinical consequences to the patient was physical pain.No defect on the product was seen before use.There was patient involvement and delay in therapy, however no report of patient harm.This captures the first of two occurrences.

• Brand Name: 15 CM (6") SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING LUER
• Type of Device: 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: 18539994
• MDR Text Key: 333486834
• Report Number: 9617594-2024-00043
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619057176
• UDI-Public: (01)00840619057176(17)280401(10)13611545
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC33094
• Device Lot Number: 13611545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONTRAST, UNK MFR