MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS® CLOSED MALE LUER

Model Number 034-CH2000S-PC

Device Problem Disconnection (1171)

Patient Problem No Information (3190)

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

The device will not be returning for evaluation.A device history review (dhr) was not completed due to the unknown lot number.The reported complaint cannot be confirmed without the returned sample.

Event Description

The event involved a spinning spiros closed male luer, purple cap that got disconnected from the syringe after a mitomycin administration when removing the syringe and the catheter.There was patient involvement; no delay in critical therapy, however there was an unspecified adverse event, known biohazard and chemo use but unknown need for medical intervention.No additional details were provided.

Manufacturer Narrative

Subsequent to the submission of the initial medwatch report, information was received from the customer that the correct list number is 034-ch2000s-pc.

• Brand Name: SPINNING SPIROS® CLOSED MALE LUER
• Type of Device: SPINNING SPIROS
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, 22790 ; MX 22790
• MDR Report Key: 7981460
• MDR Text Key: 124837054
• Report Number: 9617594-2018-00059
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619026615
• UDI-Public: 840619026615
• Combination Product (y/n): N
• PMA/PMN Number: K082806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 034-CH2000S-PC
• Device Catalogue Number: 034-CH2000S-PC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other