MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 43 CM (17") EXT SET W/2 MICROCLAVE®, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number IA-C3332

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Patient Involvement (2645)

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

The device is available for investigation.It has not been received.

Event Description

The event involved an ext set w/2 microclave, clamp, rotating luer that the customer reported during priming, the solution passed through from the y-site to the end, and air can be observed partially in several points.The customer reported that some solution drops were observed on the inner wall and there was a deformation was observed around the center of the internal cannula in the connector on the y-site.There was no patient involvement, no adverse event, and no delay in critical therapy.

Manufacturer Narrative

Received one used list # ia-c3332, 43 cm (17") ext set w/2 microclave®, clamp, rotating luer; lot # 3819248 and one used partially full w/ unknown solution, 6ml terumo syringe on november 16, 2019 at salt lake city for investigation.The used ia-c3332 extension set was confirmed to have a stick down resulting from microclave spike deformation.There was y-clave seal coring that was observed and is typical of access with an incompatible mating device during use.The mating device returned was found to be compatible with microclave and would not likely have been the cause of the seal coring.The probable cause of the microclave spike deformation resulting in a seal stick down is excessive solvent applied during manual assembly in ensenada.The probable cause of the y-clave seal coring is access with an incompatible mating device during use.The dfu states: don¿t connect the female luer of this product¿s connector to the male connector of a syringe, infusion set, etc.Having a male luer taper measuring less than 1.55 mm or more than 2.80 mm in inside diameter (because the silicone seal in the female luer may be broken, resulting in leakage of drug solution and contamination).The device history review (dhr) for lot number 3819248 was reviewed and there were no relevant non-conformances found.

• Brand Name: 43 CM (17") EXT SET W/2 MICROCLAVE®, 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: 9304543
• MDR Text Key: 187703589
• Report Number: 9617594-2019-00385
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619099237
• UDI-Public: (01)00840619099237(17)231001(10)3819248
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Catalogue Number: IA-C3332
• Device Lot Number: 3819248
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1