MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS CLOSED MALE LUER, RED CAP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number CH2000S-C

Device Problem Disconnection (1171)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device is available for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.A device history review (dhr) could not be completed due to the unknown lot number.If additional information is received, supplemental reports will be submitted.

Event Description

The event occurred on an unknown date in 2020.The customer reported a spinning spiros closed male luer, red cap that became undone and blood had spilled out of the patient's line and onto the bed.The nurse paused the chemo, followed the line, and noticed the spiros had been undone.There was patient involvement but no harm reported.This report captures the second of three events.

• Brand Name: SPINNING SPIROS CLOSED MALE LUER, RED CAP
• 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: christopher zanoni ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 10124800
• MDR Text Key: 199090745
• Report Number: 9617594-2020-00162
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CH2000S-C
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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