MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. INF.-LEITUNG ERNÄHRUNG 96H LICHTSCHUTZ; STOPCOCK, I.V. SET

Catalog Number SN1520GC

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250)

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

Event Date 03/01/2024

Event Type  malfunction  

Event Description

The complaint event occurred on an unspecified date and involved a inf.-leitung ernährung 96h lichtschutz.It was reported that the integrated 0.2 m filters simply burst when medication is injected.The situation can be recognized by a sudden loss of pressure during injection and liquid is escaping from the filter.This situation does not affect the line.There was patient involvement; however there was no report of human harm.

Manufacturer Narrative

It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not yet been received.Without the returned device, a probable cause is unable to be determined.If additional information or if a device later becomes available, supplemental vigilance report(s) will be submitted at that time.

Manufacturer Narrative

The device history record (dhr) was reviewed and no non-conformities were found that would have led the reported condition on the complaint.

Event Description

Additional information was received by the customer on12apr2024.The customer reported that the event happened sometime during (b)(6) 2024.The medication involved was a glucose/amino acid mixture (parenteral nutrition) from the in-house pharmacy.The product was stored in the facility in its original box in a cupboard storage.No chemo was noted and there was no patient harm associated with the complaint/event.

• Brand Name: INF.-LEITUNG ERNÄHRUNG 96H LICHTSCHUTZ
• 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: 18965802
• MDR Text Key: 338451973
• Report Number: 9617594-2024-00325
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619080204
• UDI-Public: (01)00840619080204(17)260101(10)13522077
• 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: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SN1520GC
• Device Lot Number: 13522077
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2023
• 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: UNSPEC. GLUCOSE/AMINO ACID MIX/INFUSATE, MFR UNK.; UNSPECIFIED MEDICATION, MFR UNK.