MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 0.2 MICRON PEDIATRIC FILTER, ROTATING LUER; STOPCOCK, I.V. SET

Model Number	B6008
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.
Event or Problem Description
The date of the event is unknown.The event involved a is 0.2 micron pediatric filter, rotating luer that the filter starts leaking (etoposide) or shows signs of cracking.It was further added that the leak occurs at the joint between the filter and the iv tubing.There was no report of patient involvement or an adverse event.

• Brand Name: 0.2 MICRON PEDIATRIC FILTER, ROTATING LUER
• Common Device Name: STOPCOCK, I.V. 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: 9913559
• Report Number: 9617594-2020-00107
• Device Sequence Number: 3257530
• Product Code: FMG
• UDI-Device Identifier: 00887709011014
• UDI-Public: (01)00887709011014(17)240701(10)4183920
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

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: 07/01/2024
• Device Model Number: B6008
• Device Catalogue Number: B6008
• Device Lot Number: 4183920
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1