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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.
Event or Problem Description
The event involved oncology kit w/spinning spiros®, c-clip, red cap which leaked unspecified chemotherapy on patient or healthcare provider.The device had been inspected prior to use and all parts were in place appropriately.No hole, cut, tears or any defect noted; it was all over the closed bag so the user could not fully manipulate.The chemo spill was cleaned up per facility protocol.There was no blood loss or bleed back.The drug was replaced and no further issues were reported.There was patient involvement, however, there was no adverse outcome as a consequence of this event.
Additional Manufacturer Narrative
A photograph of the product packaging was provided and evaluated.The spiros was not visible in the image.No product samples were returned for investigation.The dhr for lot number 5030925 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.The reported complaint cannot be confirmed based on the information that has been provided.

• 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: 11723468
• Report Number: 9617594-2021-00135
• Device Sequence Number: 19587814
• Product Code: FPA
• UDI-Device Identifier: 00887709079243
• UDI-Public: (01)00887709079243(17)251001(10)5030925
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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: 10/01/2025
• Device Catalogue Number: CH3581
• Device Lot Number: 5030925
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 04/29/2021
• 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: UNSPECIFIED CHEMOTHERAPY, MFR UNK