MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TP4 KIT W/10CC SAFESET RESERVOIR

Model Number	46104-65
Medical Device Problem Code	Failure to Prime (1492)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two (2) unused, list # 46104-65, tp4 kit w/10cc safeset reservoir, needleless valve, filter millex and admin set; lot # 3438172 were received for testing.As received, it was noted that in the sample from bag 1 the 25" high pressure tubing is separated from female luer and male luer.The tubing separations were all found to be tacky in feel with lint being stuck to the end of the tubing.There appears to be sufficient solvent at each bond location.The probable cause of the tubing separation was the uv adhesive not being fully cured.The dhr lot # 3438172 and relevant commodities were reviewed and there were no non-conformances found that would have contributed to the reported complaint.
Event or Problem Description
The event occurred on an unknown date in (b)(6) and (b)(6) 2018.The event involved a customer report stating that tp4 kit with 10cc safeset reservoir, needleless valve, filter millex and admin set would not prime as though there was a blockage in the filter that prevents fluid from passing through.The device was replaced with no further problems enountered.There was no patient involvement.

• Brand Name: TP4 KIT W/10CC SAFESET RESERVOIR
• Common Device Name: TP4 KIT W/10CC SAFESET RESERVOIR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, 22790 ; MX 22790
• MDR Report Key: 7902822
• Report Number: 9617594-2018-00054
• Device Sequence Number: 11121252
• Product Code: DRS
• UDI-Device Identifier: 00887709050846
• UDI-Public: 00887709050846
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/25/2018

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: 04/01/2020
• Device Model Number: 46104-65
• Device Catalogue Number: 46104-65
• Device Lot Number: 3438172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1