MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. EXT SET, SMALLBORE W/CLAVE¿, T-CONNECTOR INJ SITE; STOPCOCK, I.V. SET

Catalog Number 011-MC330622

Device Problems Component Missing (2306); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation, however has not been received.

Event Description

The event involved a ext set, smallbore w/clave¿, t-connector inj site.The reporter stated that the clave end was missing the rubbery seal where the syringe locks in.The team noticed before using the connector for anything.It's the part which would be furthest from the patient, where the syringe/spiros would lock on to the connector.The inner part of the locking valve is missing.The reporter stated that microclave t connector was placed on patient after intravenous (iv) catheter placement.When the operator tried to flush through with saline, it was discovered that the end seal was missing, thus making the system open.The t connector was therefore replaced.The device was changed out/replaced with no further problems encountered.There was patient involvement, however no report of patient harm.

Manufacturer Narrative

A series of photos were returned showing a 011-mc330622 extension set with the proximal end microclave having the silicone seal stuck down.No mating devices were shown.A single used 011-mc330622 extension set was returned.When returned the silicone seal was stuck down.No mating devices were returned to evaluate with the used 011-mc330622 extension set.The single used 011-mc330622 extension set was confirmed to have the silicone seal of the proximal microclave stuck down.Subsequent disassembly revealed that there was little if any lubricant on the spike tip starting at the bottom of the windows.The probable cause of the seal stick down is typical of a dry spike that occurred during assembly.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Additional information in g1 d9 date returned to mfg 8/21/2023.

• Brand Name: EXT SET, SMALLBORE W/CLAVE¿, T-CONNECTOR INJ SITE
• 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
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17312195
• MDR Text Key: 319050344
• Report Number: 9617594-2023-00362
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709098657
• UDI-Public: (01)00887709098657(17)271101(10)12717944
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-MC330622
• Device Lot Number: 12717944
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SALINE, UNK MFR; VINCRISTINE, UNK MFR