MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 41 CM (16") PUR TRANSFER SET W/CLAVE® CLEAR, CHECK VALVE W/LUER LOCK, FILTER CAP; ADMINISTRATION SETS AND ACCESSORIES

Catalog Number 011-MC9077

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 11/20/2018

Event Type  malfunction  

Manufacturer Narrative

The device is expected to return.It has not been received.

Event Description

The event involved pur transfer sets w/clave clear, check valve w/luer lock, filter caps, that prior to direct patient use, during preparation/priming of oncology medication, that the microclave was not working, the fluid did not run through the connector.It was also reported that blue cap on one end was not tightened to the tube and it fell off or it was already separated in the original packaging.There was unprotected chemo exposure reported, but there was no serious injury or harm, no medical intervention required and no delay in critical therapy.The device was replaced with no further problems encountered.

Event Description

Additional information received that the chemo exposure was relating to the closed system being faulty.There was no skin contact to hd and no one was contaminated.

Manufacturer Narrative

Four used 011-mc9077 transfer sets were returned on 12/17/2018 for testing and investigation.The devices had visible y-clave seal damage in the form of tearing/coring typical of access with an incompatible mating device with a male luer inside diameter smaller than 0.062".One of the samples had a y-clave seal stuck down when returned.No mating devices were returned to evaluate with the transfer sets.Subsequent disassembly did reveal internal spike damage typical of access with an incompatible mating device with a male luer inside diameter smaller than 0.062".The probable cause of the reported flow y-clave flow problems is damage to the y-clave typical of access during use by a mating device male luer with an inside diameter smaller than 0.062".The y-clave dfu states: the clave connector is compatible with luers with an internal diameter (id) between 1,55mm (0.062") and 2,8 mm (0.110").The blue caps on the four transfer sets were all in place on the distal male luer and had not fallen off.The lot # 3665946 and relevant commodities were reviewed and there were no non-conformances found.The date of the event occurred from (b)(6) 2018 through (b)(6) 2018.

• Brand Name: 41 CM (16") PUR TRANSFER SET W/CLAVE® CLEAR, CHECK VALVE W/LUER LOCK, FILTER CAP
• 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: 8174907
• MDR Text Key: 131384638
• Report Number: 9617594-2018-00226
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619088842
• UDI-Public: (01)00840619088842(17)230401(10)3665946
• 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,Followup
• Report Date: 11/20/2018

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: 04/01/2023
• Device Catalogue Number: 011-MC9077
• Device Lot Number: 3665946
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/20/2018
• Initial Date FDA Received: 12/18/2018
• Supplement Dates Manufacturer Received: 01/08/2019; 05/15/2019
• Supplement Dates FDA Received: 01/22/2019; 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1