MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 37" (94 CM) APPX 4.2 ML, 15 DROP SECONDARY ADMIN SET WITH BAG HANGER, ROTATING L; STOPCOCK, I.V. SET

Model Number SF3258-15H

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

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

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

No product samples were returned for investigation, however, a series of photographs were returned showing a sf3258-15h infusion set with a small white particle that was confirmed to be inside the fluid path.Examination of the photograph was unable to confirm a missing portion of the drip chamber spike tip but the photograph was not high resolution.No device history record (dhr) was reviewed because no lot number(s) was/were identified.The probable cause of the white particle inside the fluid path cannot be determined without return of the affected product assembly.

Event Description

The event involved a 37" (94 cm) appx 4.2 ml, 15 drop secondary admin set with bag hanger, rotating luer that was reported to have a foreign object in tubing of the secondary set.It appeared to be a particle from the tip of the spike that had broken off.The product was sealed, opened and immediately used.The antibiotic was spiked and the tubing was then primed.There was no patient involvement as the iv solution did not reach the patient and was never attached to infuse.There was no adverse event.

• Brand Name: 37" (94 CM) APPX 4.2 ML, 15 DROP SECONDARY ADMIN SET WITH BAG HANGER, ROTATING L
• 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: 12214136
• MDR Text Key: 263600895
• Report Number: 9617594-2021-00204
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SF3258-15H
• Device Catalogue Number: SF3258-15H
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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