MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SAFESET 24 INCH ARTERIAL PRESSURE TUBING, SAFESET RESERVOIR AND BLOOD SAMPLING; CATHETER, CONTINUOUS FLUSH

Catalog Number 423280412

Device Problem Separation Problem (4043)

Patient Problem No Patient Involvement (2645)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

One used list# 423280412, safeset¿ 24 inch arterial pressure tubing, safeset¿ reservoir and blood sampling port, possible lots 4751943 or 4853674 was received for evaluation.The reported complaint of blood sampling ports came apart was confirmed on the returned set.During visual inspection, the safeset reservoir was found separated from the one way stopcock.The one way stop cock was microscopically examined under a uv light, and insufficient adhesive was observed.The probable cause of the safeset reservoir separation had occurred due to insufficient adhesive applied during assembly process.A device history review for possible lots 4751943, 4853674 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.The lot number of the device that was in use is unknown.The customer identified two possible lot numbers (plots).The possible lot numbers are 4751943 (expiry date: 03/01/2023, mfr date 03/01/2020), and 4853674 (expiry date 05/01/2023, mfr date 05/01/2020).

Event Description

The event involved a safeset¿ 24 inch arterial pressure tubing, safeset¿ reservoir, and blood sampling port where the blood sampling port came apart during set up, prior to patient care.There was no patient involvement, and no adverse event.

• Brand Name: SAFESET 24 INCH ARTERIAL PRESSURE TUBING, SAFESET RESERVOIR AND BLOOD SAMPLING
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 10762504
• MDR Text Key: 214586146
• Report Number: 9617594-2020-00469
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932188
• 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: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 423280412
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2020
• 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