MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON F; STOPCOCK, I.V. SET

Catalog Number B33902

Device Problem Disconnection (1171)

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

Event Date 07/01/2023

Event Type  malfunction  

Manufacturer Narrative

A used list #b33902, 13" smallbore quadfuse ext set w/3 microclave® (glow, 2 red rings), 0.2 micron filter, 4 clamps, rotating luer (lot #unknown) was returned from the customer for investigation.Tpn/lipids solution residuals were observed in the device and the filter was separated from the tubing.No additional damage or abnormally were observed.No mating device was returned.No solvent was present in the return device.The complaint of disconnection/loose connection can be confirmed based or the physical sample evaluation.The probable cause was due to insufficient solvent applied during manual assembly process in manufacturing.A device history record (dhr) review could not be conducted because a lot number was not identified.

Event Description

The event occurred on an unspecified date and involved a 13" smallbore quadfuse ext set w/3 microclave® (glow, 2 red rings), 0.2 micron filter, 4 clamps, rotating luer.It was reported the tubing (containing tpn and lipids) disconnected from the filter which compromised the line of the premature neonate infant in a level 3 nicu.As a result, especially because the neonate had an underdeveloped immune system, the patient required a complete blood count (cbc) and c-reactive protein (crp) test/check for two days in a row as part of a sepsis laboratory test panel.The crp results for the patient were elevated and the cbc results were within normal limits.Further clinical impact to the patient as a result of this event is yet to be determined.Besides blood tests, just more clinical monitoring has been required.This is the fourth of four occurrences.No additional information is available at this time.

• Brand Name: 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON F
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17479156
• MDR Text Key: 320630802
• Report Number: 9617594-2023-00497
• 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: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B33902
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: UNSPECIFIED LIPIDS, MFR UNK; UNSPECIFIED TOTAL PARENTERAL NUTRITION, MFR UNK