MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 41 CM (16") PUR CLEAR/YELLOW BIFUSE ADD-ON SET W/CLAVE®, DRY SPIKE ADAPTER; STOPCOCK, I.V. SET

Catalog Number 011-H3362-10

Device Problem Fracture (1260)

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

Event Date 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.

Event Description

The event involved a 41 cm (16") pur bifuse clear/yellow add-on set w/microclave®, dry spike adapter, 10 units where it was reported when reconstituting the chemotherapy infusion during chemotherapy preparation, tubing tip broke inside the chemo tree during inserting.There was a delay in therapy due to having to remove the tip from the chemo tree using kocher forceps and 2 hours for preparation of a new chemotherapy bag.The devices were replaced and therapy was completed.There was no patient involvement and no report of patient harm.

Manufacturer Narrative

The device history review (dhr) for lot 5989721 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.

• Brand Name: 41 CM (16") PUR CLEAR/YELLOW BIFUSE ADD-ON SET W/CLAVE®, DRY SPIKE ADAPTER
• 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: 16454572
• MDR Text Key: 310375428
• Report Number: 9617594-2023-00091
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619094980
• UDI-Public: (01)00840619094980(17)270501(10)5989721
• 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
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3362-10
• Device Lot Number: 5989721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2022
• 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 CHEMOTHERAPY, UNK MFR.