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

Catalog Number 011-CH2000S-PC

Device Problem Disconnection (1171)

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

Event Date 02/23/2024

Event Type  malfunction  

Manufacturer Narrative

The device is not available for investigation.However, a photograph was provided by the customer and evaluation of the photo is pending.H6: component code description "internal part".

Event Description

The complaint event involved a spinning spiros¿ closed male luer, purple cap.Detachment was reported from an internal part of the device.The operator was involved but no consequence was reported.Docetaxel was reportedly involved in the complaint/event.Both the drug and the device were eliminated, and the dilution of the drug was redone.The event led to a delay in the delivery of unspecified therapies.The device did not present any anomalies before it was used.There were no problems or damages to the operator, nor to the patient.

Manufacturer Narrative

The complaint of separation on item 011-ch2000s-pc cannot be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.The device history record was reviewed and no non-conformities were found that would have led the reported condition on the complaint.

Manufacturer Narrative

The complaint investigated was updated on 8may2024 to include the following additional information: one photo was provided by customer illustrating (in a blue circle) the section where the detachment happened.However, based on review of the photo there were no visible detachments observed and no leaks were observed.The customer's complaint of separation could not be confirmed based on the photo review.

• Brand Name: SPINNING SPIROS¿ CLOSED MALE LUER, PURPLE 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18908992
• MDR Text Key: 337766628
• Report Number: 9617594-2024-00267
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00887709124127
• UDI-Public: (01)00887709124127(17)280901(10)13771881
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K082806
• 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,Followup
• Report Date: 05/13/2024

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: 011-CH2000S-PC
• Device Lot Number: 13771881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 04/01/2024; 05/08/2024
• Supplement Dates FDA Received: 04/30/2024; 05/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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: DOCETAXEL, MFR UNK