MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number B1115

Device Problems Break (1069); Leak/Splash (1354); Separation Failure (2547)

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

Event Date 11/24/2023

Event Type  malfunction  

Event Description

The event involved a 12" (30 cm) ext set w/1.2 micron filter, clamp, rotating luer and the customer reported that the lipid extension tubing detached from the filter.The lipid extension tubing was new and opened from the package 1 hour prior from the dislodgment of the tubing from the lipid filter.It was also reported that the lipid filter broke and there was a patient bleed from the line which was not considered clinically signficant.The set-up was replaced and therapy resumed after the event occurred, and the filter was replaced.No medical intervention required.There was patient involvement but harm was not reported as a consequence of this event.

Manufacturer Narrative

The device is not available for evaluation, however, sample pictures were provided; investigation is not yet complete.

Manufacturer Narrative

One (1) photo was shared by the customer, where is observed a missing tube where supposed to be connected into the outlet filter, the missing tube is not observed on the photo.No additional damage was observed on the photo.Complaint of separation can be confirmed based on the photo shared by the customer.However, since no product sample was received for investigation a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.The dhr reviewed couldn't be performed due to lot number for this complaint was unknown.

• Brand Name: 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER
• 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: 18387581
• MDR Text Key: 331504144
• Report Number: 9617594-2023-01192
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: B1115
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• 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