MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ONCOLOGY KIT W/CHEMOLOCK W/CHEMOCLAVE; SPINNING SPIROS W/RED CAP; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3941
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	06/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) used list# cl3941, oncology kit w/chemolock w/chemoclave, spinning spiros w/red cap lot# 4375837 and one (1) used bd syringe 30 ml were received for evaluation and visually inspected.As received, no damage or anomalies were identified.The spiros was hydrostatic pressure leak tested and leaked from the area of the o-ring/poppet interface.The reported complaint 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.A device history review for lot# 4375837 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.
Event or Problem Description
A sus voluntary event report (mw5095102) was received and stated "a spinning spiros, a controlled system transfer device manufactured by icu medical placed on the end of tubing and syringes for needless transfer to patient iv site, leaked fluorouracil upon attempted attachment to patient".Additionally, it was reported the spiros leaked from the housing on iv push into bd smartsite.The nurse was wearing personal protective equipment and the chemo spill was cleaned per facility protocol and a spill kit was used.It was reported there was unprotected chemo exposure, but no medical intervention done.

• Brand Name: ONCOLOGY KIT W/CHEMOLOCK W/CHEMOCLAVE; SPINNING SPIROS W/RED CAP
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, b.cfa. ; MX
• MDR Report Key: 10363625
• Report Number: 9617594-2020-00289
• Device Sequence Number: 19698681
• Product Code: ONB
• UDI-Device Identifier: 00887709079182
• UDI-Public: (01)00887709079182(17)240901(10)4375837
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• 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
• Report Date (Section B): 06/26/2020

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: 09/01/2024
• Device Catalogue Number: CL3941
• Device Lot Number: 4375837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 08/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1