MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. INTERN III SYSTEM SCHENKEL RECHTS; STOPCOCK, I.V. SET

Catalog Number SN1070

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

The complaint/event occurred on an unspecified date and involved the following device: intern iii system schenkel rechts.The customer reported that their red infusion system was leaking antibiotics, independent of batch/lot and also independent of the run rate.This device is used on immunocompromised patients.It was further reported that the leaking infusion system causes more frequent system changes, which poses a risk of infection.The device in question came from externally undamaged, new packaging.There were no holes, cut, tears or other defects noted.The defect was located above the filter.Sometimes the infusion system was reported to be wet and dripping.The facility indicated that they also administer the chemotherapies below the filter at the y-pieces when treating tumor diseases.The customer reported a concern with a 'potential infection at the catheter'.The operator of the device was the nursing staff.The customer reported an unspecified therapy for catheter sepsis and antibiotic.There are no relevant tests or lab data available, because the observation that a leaking system raises the suspicion as to whether external contamination also occurs and could promote a catheter infection.There was patient involvement but no patient harm.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

• Brand Name: INTERN III SYSTEM SCHENKEL RECHTS
• 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: 18700276
• MDR Text Key: 336096875
• Report Number: 9617594-2024-00150
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SN1070
• Device Lot Number: 13759007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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 ANTIBIOTIC INFUSATE, MFR UNK