MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 110" (279 CM) APPX 13.8 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ PORT DRIP; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	AHCL3300
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received: one used list# ahcl3300, 110" (279 cm) appx 13.8 ml, 20 drop admin set w/integrated chemolock¿ port drip chamber, clave®, rotating luer, bag hanger.Lot# 3124607.The reported product problem for leakage was confirmed.There was a channel leak at the bonded connection between the chemolock and the drip chamber side port.The leakage was due to the chemolock not fully engaged into the drip chamber side port.The probable cause was due to the design of the bonded connection.The bonded connection has been redesigned at the drip chamber.A dhr lot# 3124607 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.
Event or Problem Description
The event involved a 110" (279 cm) appx 13.8 ml, 20 drop admin set w/integrated chemolock¿ port drip chamber, clave®, rotating luer, bag hanger that the customer reported leaking adriamycin where the chemolock clave mated with the bag spike.The event occurred after the bag was spiked and was hanging.There was no reported harm, medical intervention, or a delay in critical therapy.

• Brand Name: 110" (279 CM) APPX 13.8 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ PORT DRIP
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• 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: 9171981
• Report Number: 9617594-2019-00336
• Device Sequence Number: 2537470
• Product Code: ONB
• UDI-Device Identifier: 00887709075696
• UDI-Public: (01)00887709075696(17)200901(10)3124607
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2019

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: No Information
• Device Expiration Date: 09/01/2020
• Device Catalogue Number: AHCL3300
• Device Lot Number: 3124607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1