MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 41 CM (16") APPX 2.7ML, EXT SET TUBING PUR AMBRATE, SPIKE, Y-CLAVE®, LUER CHECK; STOPCOCK, I.V. SET

Catalog Number 011-H1225

Device Problem No Flow (2991)

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

Event Date 04/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.Additional reporter information: (b)(6).

Event Description

The event occurred on an unknown date in (b)(6) 2023 involving a 41 cm (16") appx 2.7ml, ext set tubing pur ambrate, spike, y-clave¿, luer check valve where blockage during administration of fluorouracil (5-fu) was reported.The device was connected to an infusomat space cyto-sets; b.Braun manufacturer to 3 three different types.The problem occurred in the beginning of infusion when a nurse started to administer the medicine where there was an immediate blockage.There was unprotected chemo exposure.There was patient involvement and delay in critical therapy; however, there was no patient harm.This is the third of four events.

Manufacturer Narrative

The complaint of no flow / can't prime / difficult to prime on item 011-h1225 could not be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history report (dhr) for lot 12733917 was reviewed and no non conformities were found that would have led to the reported complaint.Additional information found in d9 - device available for evaluation.

• Brand Name: 41 CM (16") APPX 2.7ML, EXT SET TUBING PUR AMBRATE, SPIKE, Y-CLAVE®, LUER CHECK
• 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 ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17209862
• MDR Text Key: 318280568
• Report Number: 9617594-2023-00276
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619007843
• UDI-Public: (01)00840619007843(17)271101(10)12733917
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H1225
• Device Lot Number: 12733917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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: FLUOROURACIL (5-FU), MFR UNK; INFUSOMAT SPACE CYTO-SETS, B.BRAUN MFR