MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 40" (102 CM) APPX 7.3 ML, 20 DROP ADMIN SET W/INTEGRATED CLAVE® DRIP CHAMBER, 0.; ADMINISTRATION SETS AND ACCESSORIES

Catalog Number	CH3401
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As received, the new set was removed from the package.The set was hydrostatic pressure leak-tested, with the clave in the activated position, according to product specifications, and no leaks were found anywhere along the fluid path.The original set which generated the complaint was not returned, nor was the mating device.The reported complaint could not be confirmed.A device history (dhr) of the reported lot and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.
Event or Problem Description
It was reported that cisplatin was found to leak inside double chemo bags.It was reported that the clear plastic piece in the center gets pushed in when they add drugs via the connector and did not pop back out to close the valve.There was no patient involvement.No additional information is available.

• Brand Name: 40" (102 CM) APPX 7.3 ML, 20 DROP ADMIN SET W/INTEGRATED CLAVE® DRIP CHAMBER, 0.
• Common Device Name: ADMINISTRATION SETS AND ACCESSORIES
• 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: 9130414
• Report Number: 9617594-2019-00320
• Device Sequence Number: 11357141
• Product Code: FPA
• UDI-Device Identifier: 00840619068363
• UDI-Public: (01)00840619068363(17)240501(10)4090748
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K070532
• 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): 09/04/2019

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: 05/01/2024
• Device Catalogue Number: CH3401
• Device Lot Number: 4090748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1