MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. LICHTSCHUTZLEITUNG MIT 1,2 ¿M FILTER; STOPCOCK, I.V. SET

Catalog Number SN1419M

Device Problems Gas/Air Leak (2946); Air/Gas in Device (4062)

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

Event Date 09/01/2023

Event Type  malfunction  

Event Description

The incident involved a lichtschutzleitung mit 1,2 m filter on an unknown date.The reporter stated that, according to the pharmacy, the filter is defective.Air can be drawn into the line through the filter.There was unknown patient involvement and unknown patient harm.

Manufacturer Narrative

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

Manufacturer Narrative

No product samples, videos, or photographs were provided for investigation.The lot history was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.

• Brand Name: LICHTSCHUTZLEITUNG MIT 1,2 ¿M FILTER
• 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: 17737301
• MDR Text Key: 323923820
• Report Number: 9617594-2023-00699
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619040307
• UDI-Public: (01)00840619040307(17)250501(10)6000043
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SN1419M
• Device Lot Number: 6000043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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