MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING; STOPCOCK, I.V. SET

Catalog Number 12516-01

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Event Description

The event occurred on unknown date involving a 7" (18 cm) appx 0.24 ml, smallbore ext set w/microclave® clear, clamp, rotating luer where it was reported that the unspecified pump alarmed occlusion and the extension line appeared clogged with total parenteral nutrition (tpn) and lipids.The nurses also noted that the peripherally inserted central catheter (picc line) nurses have expressed similar concerns with the extension sets.There was unknown patient involvement and unknown harm.

Manufacturer Narrative

No product samples, videos, or photographs were provided for investigation.The device history report (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.

• Brand Name: 7" (18 CM) APPX 0.24 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING
• Type of Device: 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: 18483944
• MDR Text Key: 332987636
• Report Number: 9617594-2024-00020
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709047075
• UDI-Public: (01)00887709047075(17)280901(10)13769904
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/10/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 12516-01
• Device Lot Number: 13769904
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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: LIPIDS, MFR UNK; PERIPHERALLY INSERTED CENTRAL CATHETER, MFR UNK; TOTAL PARENTERAL NUTRITION, MFR UNK; UNSPECIFIED PUMP, MFR UNK