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
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation is anticipated; however, it has not yet begun.
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9617594-2019-00033
• Device Sequence Number: 13504340
• Product Code: FMG
• UDI-Device Identifier: 00840619043223
• UDI-Public: (01)00840619043223(17)230701(10)3734251
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2023
• Device Catalogue Number: 011-MC3302
• Device Lot Number: 3734251
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 04/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CAFFEINE