MAUDE Adverse Event Report: ICU MEDICAL, INC. SPINNING SPIROS, CLOSED MALE LUER; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number CH2000SC-10

Device Problems Loose or Intermittent Connection (1371); Naturally Worn (2988)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2021

Event Type  malfunction  

Event Description

Icu medical spinning spiros used to connect the chemo tubing to the patient was stripped.It would not tighten and would spin when attempting to connect and tighten it to the primary tubing.Returned to pharmacy.

• Brand Name: SPINNING SPIROS, CLOSED MALE LUER
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 11640574
• MDR Text Key: 244711852
• Report Number: 11640574
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CH2000SC-10
• Device Lot Number: 5000423
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1