MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS CLOSED MALE LUER, 10 UNITS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH2000S-10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used unit from list# ch2000s-10, spinning spiros® closed male luer, 10 units (lot# 5217360) and one bd 50 ml syringe were received.The devices were returned disconnected.As received, the spin feature of the spiros was activated and spinning freely.No spline damage or shear tab anomalies were observed.The male luer of the bd syringe was also examined and no damage was identified.The functionality of the spiros spin feature was measured and met product performance specifications.The luers of each device were measured and met iso standards for luer fittings.A photograph was provided showing a used spinning spiros disconnected from a 50 ml syringe filled with red drug residuals.No other visible damage or anomalies can be seen in the image.The reported complaint can be confirmed as the samples were returned disconnected.The probable cause of the disconnection is unknown.A device history review of lot number 5217360 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.
Event or Problem Description
The event involved a spinning spiros® closed male luer which disconnected from the luer of the syringe while the nurse was beginning to administer the chemotherapy (doxorubicin) to the patient.The drug did drip onto patient and patient's shirt; the shirt was removed, and the area was washed with soap and water.There was patient involvement, however, there was no harm reported as a consequence of this event.

• Brand Name: SPINNING SPIROS CLOSED MALE LUER, 10 UNITS
• Common Device Name: 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: 11881463
• Report Number: 9617594-2021-00165
• Device Sequence Number: 3686128
• Product Code: FPA
• UDI-Device Identifier: 00840619033910
• UDI-Public: (01)00840619033910(17)260301(10)5217360
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K082806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2026
• Device Catalogue Number: CH2000S-10
• Device Lot Number: 5217360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1