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
It is unknown if the sample will 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 is received, supplemental reports will be submitted.
Event or Problem Description
The event involves a spinning spiros closed male luer, red cap that leaked during use with doxorubicin.No additional information has been provided.
Additional Manufacturer Narrative
One (1) used list # 20130-01, spinning spiros ® closed male luer, red cap; lot # 4806299 and one (1) used 50ml bd syringe was received for evaluation.The spiros was returned with evidence of leakage at the poppet/o-ring interface.Subsequent leak testing confirmed leakage at the poppet/o-ring interface.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 4806299 was reviewed and poppet sub-components were found to have been produced during a time when molding anomalies were present.

• 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: 10313224
• Report Number: 9617594-2020-00262
• Device Sequence Number: 14318416
• Product Code: FPA
• UDI-Device Identifier: 00840619023386
• UDI-Public: (01)00840619023386(17)250401(10)4806299
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K082806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2020

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: 04/01/2025
• Device Catalogue Number: 20130-01
• Device Lot Number: 4806299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/18/2020
• 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