MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 99" (251 CM) APPX 6.8 ML, TRANSFER SET W/CHECK VALVE, NANOCLAVE® T-CONNECTOR, AN; STOPCOCK, I.V. SET

Catalog Number A1134

Device Problem Separation Problem (4043)

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

Event Date 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device is available for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.If additional information becomes available a supplemental report will be submitted.

Event Description

The event occurred on an unknown date involving a 99" (251 cm) appx 6.8 ml, transfer set w/check valve, nanoclave® t-connector, anti-siphon valve, 0.2 micron filter, luer lock where it was reported that while changing the syringe on the parenteral nutrition (pn) and went to twist the old syringe off, the thin tubing (that connects the syringe to the main bag of fluid) snapped off.The tubing was changed.There was unknown patient involved and unknown harm.This is the second of two events.

• Brand Name: 99" (251 CM) APPX 6.8 ML, TRANSFER SET W/CHECK VALVE, NANOCLAVE® T-CONNECTOR, AN
• 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: 17863094
• MDR Text Key: 324831106
• Report Number: 9617594-2023-00788
• Device Sequence Number: 1
• Product Code: FMG
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A1134
• Device Lot Number: 10619902
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2022
• 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: PARENTERAL NUTRITION (PN), MFR UNK; SYRINGE: MFR UNK