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	20130-01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.If additional information becomes available a supplemental report will be submitted.
Event or Problem Description
The event involved a spinning spiros® closed male luer, red cap where the spiros was not locking on the mating device and a leak was noted during a syringe administration of doxorubicin.It was reported that the leak was contained in a soaker pad.There was no obvious damage noted on the product.There was no blood loss or bleed back and no patient harm was noted when the issue occurred.
Additional Manufacturer Narrative
H10 - no product samples were returned for investigation; however, a series of photographs were returned showing the label of the 20130-01 spinning spiros with lot number 4749754.The actual product assembly was not shown.The lot number identified used of a molded poppet that molding anomaly on the sealing surface that can result in leakage.The probable cause of the leaking spiros is due to a molding anomaly on the sealing surface of the poppet sub-component.The device history review for lot 4749754 was reviewed and a poppet sub-component was found that a molding anomaly on the sealing surface that can lead to leakage.

• Brand Name: SPINNING SPIROS CLOSED MALE LUER, RED CAP
• 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: 10312739
• Report Number: 9617594-2020-00260
• Device Sequence Number: 11628675
• Product Code: FPA
• UDI-Device Identifier: 00840619023386
• UDI-Public: (01)00840619023386(17)250301(10)4749754
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2020

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: 03/01/2025
• Device Catalogue Number: 20130-01
• Device Lot Number: 4749754
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DOXORUBICIN, MFR UNK; UNSPEC SYRINGE, MFR BD