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 Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not been received.

Event Description

The event involved a spinning spiros® closed male luer, red cap where the spiros disconnected from back of the spiros where the luer lock is inserted on a pca tubing, with a fixed collar.There was unspecified blood loss reported, not enough to warrant a transfusion, but enough to be concerning, as the patient was a bone marrow transplant (bmt) patient with a low hemoglobin and heightened infection risk.There was also a spill of an unspecified hazardous drug, but it was reported to be a small amount since patient was on a continuous, and slow hazardous drug infusion.There was patient involvement, and no patient harm.

Manufacturer Narrative

No product samples were returned for investigation, however, a photograph was provided and evaluated.The photo shows two package labels of spiros from lots 4962306 and 4969219.No damage or anomalies are visible in the image.The device history review for lot number 4962306 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.The reported complaint cannot be confirmed based on the information provided.

• 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
• MDR Report Key: 10862350
• MDR Text Key: 217673491
• Report Number: 9617594-2020-00499
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026615
• UDI-Public: (01)00840619026615(17)250801(10)4962306
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• 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: 4962306
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPEC PCA TUBING, MFR UNK.