MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IV QUAD MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICES, STOPCOCKS, NEEDL; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 46117-18

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device will be returned for evaluation.Initial reporter facility name - (b)(6).

Event Description

The customer reported having 10-15 incidents of breaks at the tap of a transpac¿ iv quad monitoring kit w/03 ml squeeze flush devices, stopcocks, needleless valve and arterial pressure tubing that lead to a variable amount of blood loss.These events occurred over a month.There was patient involvement, but no reported harm.

Manufacturer Narrative

H10: no product samples, pictures, or videos were received for investigation.Therefore, a comprehensive failure investigation cannot be performed and a cause cannot be determined.A manufacturing record review could not be completed as the lot number was not provided by the customer.

• Brand Name: TRANSPAC¿ IV QUAD MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICES, STOPCOCKS, NEEDL
• 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; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 9238012
• MDR Text Key: 204575901
• Report Number: 9617594-2019-00363
• Device Sequence Number: 1
• Product Code: DRS
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 46117-18
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1