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	09/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned for evaluation.Investigation is not complete.
Event or Problem Description
The event involved a spinning spiros closed male luer, red cap that leaked during a subcutaneous azacitidine administration.The spiros was attached to a 5ml syringe containing the medication and the spiros was found to leak into the outer chamber and some of it made its way out of the syringe and onto the nurse's glove.There was no blood loss nor bleed back and there were no holes cuts, tears, or any defect noted on the product.There was patient involvement and no adverse event or delay in therapy reported.
Additional Manufacturer Narrative
H10 - one used list# 20130-01, spinning spiros (lot# 4957570) and one 3ml bd syringe were received and visually inspected.As received, the spiros was securely connected to the syringe.The spin feature of the spiros was activated and spinning freely.No damage or anomalies were observed.The spiros was functionally tested and met product performance specifications.No leakage was identified during testing.The reported complaint of a leaking spiros cannot be confirmed.A device history review for lot# 4957570 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.

• 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: 10623285
• Report Number: 9617594-2020-00428
• Device Sequence Number: 3735183
• Product Code: FPA
• UDI-Device Identifier: 00840619023386
• UDI-Public: (01)00840619023386(17)250801(10)4957570
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2020

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: 08/01/2025
• Device Catalogue Number: 20130-01
• Device Lot Number: 4957570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 10/22/2020
• 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: 5ML SYRINGE, MFR UNK; AZACITIDINE, MFR UNK