MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" SMALLBORE EXT SET W/1.2 MICRON FILTER, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number B1755

Device Problem Separation Problem (4043)

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

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

Two photos were shared by the customer.In photo the lot information of the item b1755 is observed and on the second photo a tube separation from the set is observed.No additional damage or anomalies were confirmed.One used sample #b1755 was returned for evaluation.As received a tubing break from the male luer was observed.A portion of the tube was found inside the male luer.No additional damage or anomalies were confirmed.Complaint of separation can be confirmed based on the used physical sample evaluation and the photos shared by customer.The probable cause is due to unintentional force applied during use.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

Event Description

The event involved a 4" smallbore ext set w/1.2 micron filter, rotating luer where it was reported that the end of the filter set came off.The event occurred during total parenteral nutrition (tpn) and lipid infusion.There was patient involvement and a delay in therapy due to a new daily bag of tpn and lipids was administered, however, no report of patient harm.

• Brand Name: 4" SMALLBORE EXT SET W/1.2 MICRON FILTER, 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: 18807003
• MDR Text Key: 337628082
• Report Number: 9617594-2024-00217
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: B1755
• Device Lot Number: 13766603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: TOTAL PARENTERAL NUTRITION AND LIPIDS, UNK MFR.