MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 51 CM (20") EXT SET W/2 SURPLUG® MICRO CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number IR-EK55011A

Device Problems Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

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

Event Date 08/10/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.Section e, additional contacts: (b)(6).

Event Description

The complaint involved a 51 cm (20") ext set w/2 surplug® micro clear, clamp, rotating luer that was originally reported to have a connection problem on the side-injection port or a defective valve.The device was connected to a 10ml terumo syringe on the main side.Upon further checking the connector on side-injection port, a tear/damage was observed on the valve.The issue was not detected prior to patient use and the reported event occurred during infusion.Computed tomography (ct) inspection was performed on the connector on side-injection, and a bend was identified in the conduit.There was no serious injury/death, no blood loss, no unprotected chemo exposure, no delay in critical therapy, no adverse operator consequences and no medical/surgical intervention required.The device was changed out/replaced with no further problems encountered.Although a patient was involved, there was no harm as a result of this complaint/issue/event.

Manufacturer Narrative

A series of photos were shared by customer that illustrate ct scans of two microclaves labeled ¿side injection port (y-side) and ¿main injection port¿.One used item #ir-ek55011a was also returned for evaluation.One of the microclaves from the device had a tear condition.It was disassembled and the following observations were made: body - no damage or anomalies were observed.Spike - it was found in a bent and damage.Seal - a tear condition was observed.The other microclave from the returned device did not have a tear condition and was dissembled and the following observation were made: body ¿ no damage or anomaly were observed.Spike - well lubrication on spike and no damage.Seal ¿ no significant damage were observed.Engineering analysis of the reported product issues ¿connection error in the side-injection port or defective valve¿ identified internal damages on the spike and seal of one microclave from the returned ir-ek55011a extension set that could have occurred during usage and not during the dissection/destruct testing performed by terumo.Complaint of holes/cut/torn can be confirmed based on the physical sample evaluation.The probable cause of the damage to the microclave aligns with the use of an incompatible mating device.The directions for use (dfu) states: the clave connector is compatible with luer with an internal diameter (id) between 1.55mm and 2.8mm.The lot production history records were reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 51 CM (20") EXT SET W/2 SURPLUG® MICRO CLEAR, 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
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17780069
• MDR Text Key: 323812008
• Report Number: 9617594-2023-00736
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IR-EK55011A
• Device Lot Number: 13558081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2023
• 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: 10ML SYRINGE, MFR TERUMO