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	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The list and lot number of the device was identified as part of a voluntary recall.Icu medical is notifying affected customers via a letter requiring removal of the affected products from the market.
Event or Problem Description
The event involves a spinning spiros closed male luer, red cap that leaked doxorubicin at the beginning of an infusion.The nurses report the leak occurs from either the joint between the white cap and the grey-ish cylinder (spiros) or from the spiros itself.Additionally, they said it was not leaking where the syringe was connected to the white cap, therefore it was not a question of the device being wrongly connected.There was no contact of chemotherapy on the patient of healthcare provider.The chemo spill was cleaned per facility protocol since there were a few droplets on a double-thick waterproof towel.There was no obvious hole, cut, crack, rupture or defect noted on the spiros.The defective syringe and spiros were discarded, and the whole thing was replaced.There was patient involvement, but no harm reported.
Additional Manufacturer Narrative
H10: no product samples, videos, or photographs were returned for investigation.The device history review for lot 4749754 was reviewed and a poppet sub-component was found that had a molding anomaly on the sealing surface that can lead to leakage.The reported complaint of a leaking spiros can be confirmed.The probable cause of the leaking spiros is due to a molding anomaly on the sealing surface of the poppet sub-component.

• 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: 10532651
• Report Number: 9617594-2020-00393
• Device Sequence Number: 16869454
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 08/18/2020
• Supplement Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 09/14/2020
• Supplement Report FDA Received Date: 10/01/2020
• 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; UNSP SYRINGE, UNK MFR