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 Codes	No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation.It has not been received.
Event or Problem Description
The event involved a spinning spiros® closed male luer, red cap that the customer reported a leak of gemcitabine.The spiros was attached to a bd alaris iv line.The healthcare provider was wearing proper personal protective equipment (ppe).There was patient involvement and the chemotherapy landed on the skin of the patient, however, the area was cleaned per protocol and there was no report of patient harm.
Additional Manufacturer Narrative
H10: no product samples, videos, or photographs were returned for investigation, however, the dhr for lot 4749754 was reviewed and there were molding irregularities found with the poppet component that can lead to leakage.The complaint of leakage is confirmed.The probable cause of the leaking spiros is due to a molding anomaly on the sealing surface of the poppet sub-component.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.

• 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: 10424487
• Report Number: 9617594-2020-00329
• Device Sequence Number: 2562009
• 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): 07/28/2020

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: 07/30/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 09/25/2020
• 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: ALARIS TUBING, MFR BECTON DICKINSON.; GEMCITADINE, MFR UNK.