MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 37" (94 CM) APPX 4.2 ML, 15 DROP SECONDARY ADMIN SET WITH BAG HANGER, ROTATING L; STOPCOCK, IV SET

Model Number	SF3258-15H
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.
Event or Problem Description
The customer contact reported the tubing set is leaking an unspecified chemotherapy drug at the junction of the iv set spike and bag or at the vent.Additionally, the date of the event is unknown.No further information has been provided.
Additional Manufacturer Narrative
Mfr site: contact name.On april 03, 2019, testing and investigation received the product involved in the event.The sf3258-15h tubing set was returned with a teva adapter attached to the distal end, with the vent cap on the drip chamber closed.The teva adapter was removed from the set, which was pressure leak tested with the vent cap closed.There was no leak observed; however, when the vent cap was opened and the set primed at gravity pressure, a leakage was observed from the drip chamber vent.Subsequently, the vent housing was removed from the drip chamber; testing confirmed the filter vent disk was not affixed to the vent housing.It remained at the bottom of the drip chamber vent housing.Further leak testing identified a leak around the rim of the filter vent material.The probable cause of the filter vent disc separation was an insufficient weld to the vent housing, that occurred at the drip chamber supplier.A manufacturing batch review for the lot #3944661 and relevant commodities were reviewed and no non-conformances were found that would have contributed to the reported complaint.

• Brand Name: 37" (94 CM) APPX 4.2 ML, 15 DROP SECONDARY ADMIN SET WITH BAG HANGER, ROTATING L
• Common Device Name: STOPCOCK, IV SET
• 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. 22790 ; MX 22790
• MDR Report Key: 8434568
• Report Number: 9617594-2019-00085
• Device Sequence Number: 1253537
• Product Code: FMG
• UDI-Device Identifier: 00840619046200
• UDI-Public: (01)00840619046200(17)240101(10)3944661
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2019

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: 01/01/2024
• Device Model Number: SF3258-15H
• Device Catalogue Number: SF3258-15H
• Device Lot Number: 3944661
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 04/12/2019
• 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: SODIUM CHLORIDE 250ML.