MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" (20 CM) APPX 0.98 ML, EXT SET W/2 MICROCLAVE® CLEAR (RED RING), CHECK VALVE,; STOPCOCK, I.V. SET

Catalog Number 011-MC330400

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

One used and one new sample were returned for evaluation.The used sample was visually inspected and y-clave was found torn, stuck down and the spike was damaged inside the housing.The stick down and tearing to the silicone seal would cause the microclave to leak.The reported issue was verified.The tearing and damage found on the microclave silicone seal and spike are typical of use of an incompatible mating device.The probable cause is that the male luer internal diameter of the mating device used was not compatible with the microclave.The direction for use (dfu) states- the microclave connector is compatible with luers with an internal diameter (id) between 1,55 mm and 2,8 mm.One new sample was visually inspected and leak testing without any issues noted.A lot review was performed with no issues noted.

Event Description

The customer reported that a 8" (20 cm) appx 0.98 ml, ext set w/2 microclave® clear (red ring) leaked.It was further reported that blood was coming out of y-site microclave, this occurred during infusion sometime in may.There was patient involvement with significant blood loss, but following device change-out, the patient maintained baseline condition.There was no adverse event, delay in critical therapy or medical intervention.

• Brand Name: 8" (20 CM) APPX 0.98 ML, EXT SET W/2 MICROCLAVE® CLEAR (RED RING), CHECK VALVE,
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: emily arnould, bsn, rn ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 8679652
• MDR Text Key: 147379735
• Report Number: 9617594-2019-00166
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619095574
• UDI-Public: (01)00840619095574(17)230501(10)3686770
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Catalogue Number: 011-MC330400
• Device Lot Number: 3686770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1