MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED SPIROS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number UNKNOWN

Device Problem Disconnection (1171)

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

Event Date 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Event Description

The event involved an unspecified spiros where it was stated in the report that the spiros cap, (connected to primary tubing running normal saline) would not connect to patient port max zero.When screwed on, spiros would immediately unscrew and disconnect.The spiros cap was replaced with a new one that worked, and infusion was started.There was patient involvement and unknown patient harm reported.

Manufacturer Narrative

Received one used list# unknown spinning spiros for inspection attached to an unknown set and one used list #unknown spinning spiros disconnected from an unknown set.As received, the spin feature on each of the spiros was activated and spinning freely as received.There was no spline damage observed.There were no damages observed on the female luer of each spiros.Each spiros was functionally tested and met product performance specifications.The reported complaint of disconnection can be confirmed on one of the spiros due to the spiros being returned disconnected.The probable cause of the disconnection could not be determined.A device history review (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: UNSPECIFIED SPIROS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 18358276
• MDR Text Key: 331226441
• Report Number: 9617594-2023-01182
• Device Sequence Number: 1
• Product Code: FPA
• 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: 02/29/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 02/29/2024
• 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
• Treatment: MAX ZERO PORT, UNK MFR; NORMAL SALINE, UNK MFR; UNSPECIFIED PRIMARY TUBING, UNK MFR