MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ONCOLOGY KIT W/SPINNING SPIROS, C-CLIP, RED CAP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH3581
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device will be returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.Additional contact person from section f4 and f5 of ufmw ¿ (b)(6) ; phone number - (b)(6).
Event or Problem Description
A medsun mandatory medwatch report (uf/importer reporter(b)(4)) was received which stated the following: ¿i was priming busulfan for a patient with iv 3 port tubing and spiros c-clip.Spiros appeared to connect appropriately to end of tubing, blue safety clip snapped in appropriately as well.After i finished circle priming the chemo i noticed it leaking from the point where the spiros connects to the tubing and is not supposed to be able to move or disconnect.I rechecked connection and connection seemed secure and not to be moving or to disconnect in any way.I placed chemo and tubing in chemo bag.Several minutes later when observing leak through chemo bag spiros disconnected completely from the iv tubing.¿ it was also reported that the original intended procedure was preparing chemo infusion and that the device failed (e.G broke, couldn¿t get it to work or stopped working), the event happened at hospital in the patient¿s room and the approximate age of the device was 1 day.The event occurred on an unknown date in (b)(6) 2020.

• Brand Name: ONCOLOGY KIT W/SPINNING SPIROS, C-CLIP, 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: 10871752
• Report Number: 9617594-2020-00510
• Device Sequence Number: 2521746
• Product Code: FPA
• UDI-Device Identifier: 00887709079243
• UDI-Public: (01)00887709079243(17)250401(10)4799815
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

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: CH3581
• Device Lot Number: 4799815
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1