MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 19 CM (7.5") PUR SMALLBORE EXT SET W/NANOCLAVE, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number 011-A1113

Device Problems Fluid/Blood Leak (1250); Dent in Material (2526)

Patient Problem Infiltration into Tissue (1931)

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not been received.Concomitant product - cec 28g, mfr vygon, reference (b)(4), lot 11022ogo; fentanyl, mfr unk; unspec parenteral nutrition.

Event Description

The event occurred in the neonatology section of the facility and involved a 19 cm (7.5") pur smallbore ext set w/nanoclave®, clamp, rotating luer, ln 011-a1113.The customer reported an issue with the non-return valve, stating the silicone sleeve of the nanoclave stays stuck and the valve was unusable as it had no anti-reflux function.The neonatology staff stated that a leak was noted in the baby¿s bed while infusing fentanyl 0,594 mg continuously at 0,2 ml/h and parenteral nutrition 63,5 ml at 2,6 ml/h, and that the leak occurred less than 10 hours into the infusion.The device was immediately replaced and therapy resumed.There was no physical damage noticed on the tubing, there was no blood loss reported.The customer reported there was an increased risk of infection on a central line, additional manipulation was necessary to change the device.The customer reported that the nanoclave connector was attached directly to the patient¿s catheter.The compromised extension (nanoclave) was in use for 3 weeks, the bag-octopus extension was in use for less than 24 hours and the octopus extension connected to the nanoclave was in use for 96h (changed every 96h).The next day, the patient¿s central catheter was changed and it was reported that the arm of the patient turned hard and red.The customer reported that apart from the patient's arm turning hard and red, there were no other consequences.The only medical intervention required was replacing the connector.

Manufacturer Narrative

D10 - date returned to mfr - 7/8/2020.H10 - one used list# 011-a1113, 19 cm (7.5") pur smallbore ext set w/nanoclave®, clamp, rotating luer (lot# 4496163) was received and visually inspected.As received, the silicone seal was stuck down and torn.The slide clamp was also missing from the assembly.It is unknown if the clamp was present when received by the customer.Crazing was also observed on the female luer of the nanoclave.The probable cause of the crazing is due to environmental stress during use.No mating devices were returned.Subsequent disassembly of the nanoclave revealed the seal was torn and punctured through the side wall.Molding damage consistent with a needle strike was also identified on the spike.The reported complaint of a seal stick down resulting in leakage can be confirmed.The seal damage observed would result in internal leakage which can lead to a stick down.The probable cause of the seal tearing is access with an incompatible mating device during use.The dfu states: the microclave connector is compatible with luers with an internal diameter (id) between 0.062" and 0.110".Do not use needles or luer caps on claves.A device history review (dhr) for lot# 4496163 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.Additional information can be found in section g1.D11 - additional concomitant device: 15 cm (6") appx 1.1 ml, smallbore quadfuse ext set w/4 nanoclave® (red ring), 3 check valves, 4 clamps, rotating luer with list number 011-a1112, lot number unknown, mfr icu medical.

• Brand Name: 19 CM (7.5") PUR SMALLBORE EXT SET W/NANOCLAVE, CLAMP, ROTATING LUER
• 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; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 10163611
• MDR Text Key: 200317060
• Report Number: 9617594-2020-00185
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619076184
• UDI-Public: (01)00840619076184(17)241201(10)4496163
• 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: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 011-A1113
• Device Lot Number: 4496163
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 MO