MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 0.41 ML, SMALLBORE EXT SET W/CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number 144020460

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/13/2024

Event Type  malfunction  

Event Description

It was reported that a 60 "(152 cm) appx 0.41 ml smallbore ext set w/clamp rotating luer generated a leak during patient use.The report stated that tubing was leaking at the connection site to the medication syringe.The event happened in the pharmacy on a patient with precedex.There were no holes, cuts, tears, or any visible defects.There was no bleed back, no blood loss and another unknown medication was back flowing into the syringe resulting in having to discard both medications and remake.There was no harm reported.

Manufacturer Narrative

One (1) used.List #144020460 was returned for evaluation.As received a crack and crazing were observed on the female luer and precedex residuals inside the set.No mating device was returned for evaluation.The set was tested as per procedure and leaks coming from the crack on the female luer was confirmed.The complaint of leaks can be confirmed.The probable cause of the crack is due to environmental stress during use.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 60" (152 CM) APPX 0.41 ML, SMALLBORE EXT SET W/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: 19102775
• MDR Text Key: 340464756
• Report Number: 9617594-2024-00426
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709094154
• UDI-Public: (01)00887709094154(17)281101(10)13833041
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 144020460
• Device Lot Number: 13833041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2023
• 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: PRECEDEX, UNK MFR; UNSPECIFIED FLUID, UNK MFR