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

Catalog Number 46109-86

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 08/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event involved a single line transpac® iv monitoring kit w/03 ml squeeze flush device, needleless valve and 10 cc contamination sheath syringe that the customer reported the tubing pulled out of the sampling valve during set up.The nurse was made aware during the priming process.There was no patient involvement, no adverse event, no patient harm, and no report of delay in therapy.

Manufacturer Narrative

Received one used and partial list# 46109-86, single line transpac® iv monitoring kit w/03 ml squeeze flush device, needleless valve and 10 cc contamination sheath syringe.Lot# 4785013.The reported complaint of tubing pulled out of the sample valve was not confirmed.No visual anomalies were observed on the returned set.The 4-way swabable luer valve was connected to a pressure tubing (engineering sample).The set was then primed and pressure leak tested, no leaks were observed.The product had performed per the specifications.A device history review (dhr) lot# 4785013 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: SINGLE LINE TRANSPAC IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, NEEDLELESS
• 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: 10487791
• MDR Text Key: 205875242
• Report Number: 9617594-2020-00365
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00887709050945
• UDI-Public: (01)00887709050945(17)230401(10)4785013
• Combination Product (y/n): N
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Catalogue Number: 46109-86
• Device Lot Number: 4785013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Date Manufacturer Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1