MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. BIFURCATED MONITORING KIT W/TRANSPAC IV, 03 ML SQUEEZE FLUSH AND SAFESET RESER; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-46107-28

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.Investigation is not yet complete.

Event Description

The event involved a bifurcated monitoring kit w/transpac that the customer reported it was discovered during priming that the 3 way tap section was not bonded.Saline was used to prime the product.The customer stated there was no traces of cut in the set and the set was immediately replaced and the therapy was resumed without any problem.There was no patient involvement, no patient harm, and no one was harmed as a result of the event.

Manufacturer Narrative

Received one partial list# 011-46107-28, bifurcated monitoring kit w/transpac® iv, 03 ml squeeze flush and safeset¿ reservoir w/needleless valve.Lot# 4735409.The reported complaint of arterial line separation was confirmed.During visual inspection, the 36" pressure tubing was found separated from the red female luer.The pressure tubing was found tacky.A pull test was conducted on a representative uv bonds, between the 36" pressure tubing and the male luer.The tubing broke near the luer above the specifications limit.The probable cause of the tubing separation had occurred due to the uv adhesive at the bond between the arterial tubing and the female luer was not fully cured.The probable cause of this defect was due to a manual manufacturing error.A device history reivew (dhr) lot# 4735409 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: BIFURCATED MONITORING KIT W/TRANSPAC IV, 03 ML SQUEEZE FLUSH AND SAFESET RESER
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 10441517
• MDR Text Key: 204019019
• Report Number: 9617594-2020-00334
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619060787
• UDI-Public: (01)00840619060787(17)230201(10)4735409
• Combination Product (y/n): N
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Catalogue Number: 011-46107-28
• Device Lot Number: 4735409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1