MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® (RED, GLOW RINGS), 0.2 MICRON FILTE; ADMINISTRATION SETS AND ACCESSORIES

Catalog Number K7042-001

Device Problem Backflow (1064)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

The device is expected to return to the manufacturer for testing and investigation.It has not yet been received.

Event Description

The event involved a customer report stating that the clave on the white port of the trifuse extension set stayed depressed.It was further reported that lipids were noted to back up into the red and blue lines of the trifuse filter.With concerns for sterility, the central line was removed and a new central line was inserted.

Manufacturer Narrative

The reported product problem for silicone seal stuck down on one of the shuntless microclaves was confirmed.The damage found on the silicone seal (coring) and the spike bent (necked) of the microclave was typical of use of an incompatible mating device with a small internal diameter (id) that is not compatible with the microclave.The directions for use (dfu) calls out microclave connectors are compatible with iso male luers having an internal diameter between 0.062" and 0.110".The mating device was not returned for investigation.A dhr lot#3758163 and relevant commodities were reviewed and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: 7" SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE® (RED, GLOW RINGS), 0.2 MICRON FILTE
• Type of Device: ADMINISTRATION SETS AND ACCESSORIES
• 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: 8473913
• MDR Text Key: 140672296
• Report Number: 9617594-2019-00103
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709036802
• UDI-Public: (01)00887709036802(17)230801(10)3758163
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2023
• Device Catalogue Number: K7042-001
• Device Lot Number: 3758163
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/12/2019
• Initial Date FDA Received: 04/02/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIPIDS.; LIPIDS