MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 41 CM (16") APPX 2.7 ML, PUR SET LINEARE CON Y-CLAVE®, BCV, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number 011-H1267

Device Problem Material Separation (1562)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2023

Event Type  malfunction  

Event Description

The event involved a 41 cm (16") appx 2.7 ml, pur set lineare con y-clave®, bcv, luer lock.It was reported the y connection is not stable.This means that it can fall apart.Only by chance no major damage has occurred so far.It was noted they test every piece of equipment before we use it.Nevertheless, one piece of equipment fell apart during chemotherapy.I have 1 defective y-clave that was only in contact with nacl 0.9 %.There was patient involvement, there was no blood loss, no adverse operator consequences, no intervention required and there was an unprotected chemo exposure, however there was a delay in critical therapy.Chemotherapy had to be interrupted and the cutlery change.The status of the patient returned to baseline condition.There was patient involvement, but no harm reported.

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.Plots: 9504310 mfr date: 10/1/2022 expiration date: 10/1/2027 13500580 mfr date: 2/1/2023 expiration date: 1/1/2028 additional reporter: (b)(6).

Manufacturer Narrative

A photo was returned showing a used 011-h1267 assembly with one of the side arms separated at the bond between the trifurcated adapter and the female luer adapter.The used 011-h1267 assembly was returned with one of the side arms confirmed to be separated at the bond between the trifurcated adapter and the female luer adapter.The bond interface was inspected and found to have insufficient solvent coverage that led to the bond separation.The probable cause of the bond separation is typical of insufficient solvent coverage at the bond interface during manual bonding assembly at the manufacturing plant.The lot histories were reviewed and no nonconformities were identified that may have contributed to the reported complaint.Product was received 9/15/2023.

• Brand Name: 41 CM (16") APPX 2.7 ML, PUR SET LINEARE CON Y-CLAVE®, BCV, LUER LOCK
• 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: 17844822
• MDR Text Key: 324791042
• Report Number: 9617594-2023-00777
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H1267
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: UNSPECIFIED CHEMOTHERAPY DRUG, MFR UNK.