MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 73" (186 CM) APPX 8.9 ML, 20 DROP ADMIN SET W/15 MICRON FILTER, CLAVE®, ROTATING; STOPCOCK, I.V. SET

Catalog Number 011-C5060

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/29/2022

Event Type  malfunction  

Event Description

The event involved a 73" (186 cm) appx 8.9 ml, 20 drop admin set w/15 micron filter, clave®, rotating luer where the reporter stated that a dirty spot stuck in luer lock during out of package.There was no patient involvement and no patient harm.No additional information involved.

Manufacturer Narrative

The device was received for evaluation.The investigation is not yet complete.Distributor information: (b)(4).

Manufacturer Narrative

Received one used list #73" (186 cm) appx 8.9 ml, 20 drop admin set w/15 micron filter, clave®, rotating luer with lot #5216782.Received photos showing brown spots on the male luer.The complaint of brown spot on the male luer can be confirmed on the returned device.As received there were multiple brown spots observed on the male luer of the set.The brown spot were observed to be embedded in the wall and not in the fluid path.There brown spots are burnt material embedded in the wall during the molding process.The most probable cause is burnt material embedded in the wall of the male luer during the molding process in salt lake city.While the device fails visual inspection, the embedded material is not in the fluid path, and does not affect the functionality of the device.The device history record (dhr) was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: 73" (186 CM) APPX 8.9 ML, 20 DROP ADMIN SET W/15 MICRON FILTER, CLAVE®, ROTATING
• 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: 15694800
• MDR Text Key: 307160912
• Report Number: 9617594-2022-00293
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-C5060
• Device Lot Number: 5216782
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2021
• 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