MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ADMIN SET WITH CLAVE¿; STOPCOCK, I.V. SET

Catalog Number 011-C5060

Device Problem Crack (1135)

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

Event Date 12/25/2023

Event Type  malfunction  

Event Description

It was reported that an admin set with clave was cracked in the central venous pressure (cvp) tube after chemo drug infusion.The event occurred after infusion.There was a concomitant drug with no concomitant device involved.There was no bleedback, with unknown chemo, no biohazard, and an unknown user facility medwatch.The device was not reprocessed, resterilized.The sample is not available for return since it was discarded.A sample photo is available showing the involved product that appears to have a crack.There was no patient harm reported.This is one of two reports.

Manufacturer Narrative

Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.

Manufacturer Narrative

The reported complaint was confirmed based on the images provided.No sample was returned for evaluation.However, images were provided by the customer showing the involved product.Without the return of the reported sample, a probable cause cannot be determined.The dhr for lot 13655228 was reviewed and no nonconformities were found that would led to the reported complaint.

• Brand Name: ADMIN SET WITH CLAVE¿
• 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: 18681798
• MDR Text Key: 336307382
• Report Number: 9617594-2024-00133
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-C5060
• Device Lot Number: 13655228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2023
• 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: UNSPECIFIED CHEMO, UNK MFR.