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
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.Investigation is not yet complete.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9617594-2020-00365
• Device Sequence Number: 2925571
• Product Code: DRS
• UDI-Device Identifier: 00887709050945
• UDI-Public: (01)00887709050945(17)230401(10)4785013
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/16/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1