MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT, 84", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MAC; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	425850405
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used list# 425850405, monitoring kit was received for evaluation.The reported complaint of "pressure tubing connection was leaking" was confirmed.No visual anomalies were observed.When primed and pressure leak tested, a channel leak was observed from the pressure tubing and the male luer.A pull test was conducted between the bonds through which a channel leak was observed.The tubing pulled off from the luer at 13.3 lbs which is above the specification limits of 6 lbs.When the bond surface of the pressure tubing was examined, insufficient solvent was observed on one side of the pressure tubing through which a channel leak was observed.The probable cause of the channel leak between the pressure tubing and the male luer had occurred due to insufficient solvent applied during assembly process.A device history review (dhr) for lot# 3981038 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.
Event or Problem Description
The event occurred in the operating room and involved a transpac iv monitoring kit, 84¿ disposable transducer, 3 ml squeeze flush, macrodrip that during priming, the pressure tubing connection right after the flush device was leaking.The device was replaced.There were no obvious defects noted on the tubing and there was no mating device attached on the tubing.There was no serious injury, death or potential for death or serious injury, the product was not used on a patient at the time of the incident and there was no delay critical therapy when the problem was noted.

• Brand Name: TRANSPAC® IV MONITORING KIT, 84", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MAC
• 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: 9944395
• Report Number: 9617594-2020-00110
• Device Sequence Number: 11732820
• Product Code: DRS
• UDI-Device Identifier: 00840619033804
• UDI-Public: (01)00840619033804(17)220201(10)3981038
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K061573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: 425850405
• Device Lot Number: 3981038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1