MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30 CM (12") APPX 3.1 ML, ADD-ON SET W/4 CLAVE®, VENTED CAP; STOPCOCK, I.V. SET

Catalog Number 011-H3315

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/10/2023

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.

Event Description

The event involved a 30 cm (12") appx 3.1 ml, add-on set w/4 clave®, vented cap on an unspecified date.It was reported that the chemo device ¿trees¿ leaked a cytotoxic medication and exposed the nurse.The valve was totally separated from the tubing.No harm was reported.

Manufacturer Narrative

One (1) photo was shared by customer, where is observed that one of the classic clave it's separated from the trifurcate.One (1) used sample list #011-h3315 connected into an unknown, plum set inserted into chloride de sodium fresenius 250 ml intravenous bag were returned for evaluation.As received half of the adaptor was found broken inside the trifurcate and marks that suggested a bending force was applied were observed and the missing classic clave was not returned for evaluation.No additional damage were observed.The complaint of separation can be confirmed based in the evidence provided by customer (photo and the physical sample).The probable cause is typical due to an bending force applied during use.A device history lot review was performed and no discrepancy or non-conformances were observed that may lead the condition reported in this complaint: additional information d9- product was received 8/9/2023.

Event Description

Additional information was provided june 20, 2023 the incident did not occur during patient use.No adverse events.No human harm.The incident occurred while connecting the products.No delay in therapy, no need for medical intervention, no blood loss, no physical defects noted before use.No leakage noted following this incident.No medical intervention required for the liberal nurse.

• Brand Name: 30 CM (12") APPX 3.1 ML, ADD-ON SET W/4 CLAVE®, VENTED CAP
• 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: michael visocnik ; .; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17172205
• MDR Text Key: 318119857
• Report Number: 9617594-2023-00257
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Public: (01)(17)271001(10)10228170
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3315
• Device Lot Number: 10228170
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 06/20/2023; 08/15/2023
• Supplement Dates FDA Received: 07/18/2023; 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2022
• 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: UNSPECIFIED CYTOTOXIC MEDICATION, UNKNOWN MFR