MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CLAVE¿ CONNECTOR IV BAG ACCESS DEVICE; STOPCOCK, I.V. SET

Catalog Number 011-CS-10

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been received for evaluation.Testing is not complete.

Event Description

The event occurred on various unspecified dates involving 6 clave¿ connector iv bag access devices with various lots where blue particles were reported to be present at the base of the opening of the fluid path in the fresenius kabi free flex bag after the bag was spiked with the device, either in preparation for compounding or immediately after compounding.The customer reported there was friction as it is inserted deeper into the bag.There was no patient involvement, no adverse event, and no delay in critical therapy.This report reflects 1 of 6 events.

Manufacturer Narrative

H10 - one used list# 011-cs-10, clave¿ connector iv bag access device, lot# unknown and one used fresenius kabi free flex bag 100 ml sodium chloride 0.9% were returned for evaluation.A visual evaluation of the sample showed that the 011-cs-10 bag spike was inserted into the blue port of the 100ml fresenius kabi free flex bag.A blue particle was visible near the spike tip on the sample.The 011-cs-10 bag spike was removed from the blue port of the bag and a small blue particle was noted near the tip of the bag spike.During testing, the blue port of the bag was examined and found to have evidence of flash around the outer rim of the port that was either shed or had torn from the blue port.The bag and fluid contents along with the bag spike was flushed and filtered.Small blue particles and strands were observed after filtering.The fresenius kabi bag port was then sectioned, and no damage was noted.The icu medical bag spike was also measured and found to meet specifications.The spike tip and shaft are designed and manufactured without sharp edges or corners exposed that would skive a mating device port and there was no skiving damage noted inside the port when sectioned.The source of the blue particles and strands were determined to be shed material from the blue bag spike port flash on the fresenius kabi free flex bag while inserting compatible bag spike into the port.No device history review (dhr) was conducted since no lot number was identified.

• Brand Name: CLAVE¿ CONNECTOR IV BAG ACCESS DEVICE
• 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; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 8941930
• MDR Text Key: 198331245
• Report Number: 9617594-2019-00287
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: K082836
• 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: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-CS-10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/20/2019
• Date Manufacturer Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS KABI FREE FLEX BAG.