MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED SET; NOT PROVIDED

Catalog Number UNKNOWN

Device Problem Break (1069)

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

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device is available for evaluation.It has not been received.

Event Description

The event occurred on an unknown date involving an unspecified set where it was reported that it had a broken filter.There was unknown patient involvement and unknown harm.No further information was provided.

Manufacturer Narrative

D9 - date returned to mfg on 12/12/2023.Received one (1) used list #unknown primary plum set for inspection.The tubing was observed to be torn.The set was tested per product specifications.There was leakage from the torn tubing.The reported complaint of leakage can be confirmed due to the torn tubing.The probable cause is due to an unintentional pulling force during use.

• Brand Name: UNSPECIFIED SET
• Type of Device: NOT PROVIDED
• 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: 18426500
• MDR Text Key: 331984667
• Report Number: 9617594-2024-00001
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 02/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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