MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SMALLBORE BIFUSE EXT SET W/2 CHEMOCLAVE®, SPIROS® W/RED CAP; PRIMARY IV SET

Catalog Number	CH3699
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation however it has yet to be received.As additional information is obtained, a supplemental report will be submitted.
Event or Problem Description
It was reported, on an unspecified date, the extension set disconnects at the connection points and can spray chemo chemicals on patient and staff.The event was reported to have occurred during patient use.There was unknown patient harm reported.As additional information becomes available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information can be found in concomitant medical products.The device was not received by the manufacturer, therefore, no device evaluation was performed.However, a device history review (dhr) was conducted and showed no non-conformances found that would have contributed to the reported complaint.No additional information is available at this time.

• Brand Name: SMALLBORE BIFUSE EXT SET W/2 CHEMOCLAVE®, SPIROS® W/RED CAP
• Common Device Name: PRIMARY IV SET
• 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: 8175239
• Report Number: 9617594-2018-00227
• Device Sequence Number: 1684166
• Product Code: FMG
• UDI-Device Identifier: 00887709089174
• UDI-Public: (01)00887709089174(17)230901(10)3782764
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2018

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: 09/01/2023
• Device Catalogue Number: CH3699
• Device Lot Number: 3782764
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 12/31/2018
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1