MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18CM) APPX 0.25 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING L; IV CONNECTOR AND SETS, INTRAVASCULAR ADMINISTRATION SETS

Catalog Number 011-MC3302

Device Problem Fluid/Blood Leak (1250)

Patient Problem Injury (2348)

Event Date 01/24/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluation is anticipated; however, it has not yet begun.

Event Description

The customer contact reported the extension set leaked at the level of the valve, while connected to a 5-way extension set, during an infusion of caffeine.There was a pediatric patient involved and an unspecified adverse event.No further information was provided.

Manufacturer Narrative

On march 11, 2019, testing and investigation received the tubing set involved in the event with a 3ml syringe connected to the microclave.The reported leak was confirmed.Additionally, the silicone seal in the microclave was found to be torn, stuck down, and the spike was bent inside the housing, which is typical with the use of an incompatible mating device (not returned for evaluation).The probable cause is due to the internal diameter of the male luer is not compatible with the microclave.A manufacturing batch record review for the lot #3734251 was completed; there were no non-conformances identified with the product.

• Brand Name: 7" (18CM) APPX 0.25 ML, SMALLBORE EXT SET W/MICROCLAVE® CLEAR, CLAMP, ROTATING L
• Type of Device: IV CONNECTOR AND SETS, INTRAVASCULAR ADMINISTRATION SETS
• 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: 8327889
• MDR Text Key: 135847429
• Report Number: 9617594-2019-00033
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619043223
• UDI-Public: (01)00840619043223(17)230701(10)3734251
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• 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: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Catalogue Number: 011-MC3302
• Device Lot Number: 3734251
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CAFFEINE