MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DISCOFIX®; ACCESSORIES, CATHETER

Catalog Number	456003
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved was confirmed not to be available for evaluation.Without the actual device, a thorough investigation could not be performed and the reported defect was not confirmed.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample becomes available, a follow up will be submitted.
Event or Problem Description
As reported by the user facility: the stopcock leaked blood during use.While returning blood to patient through a closed system, approximately 2-3 cc of blood leaked out of the distal stopcock connection onto the patient and the patient's mother.The patient's closed system was then flushed with 10 cc of normal saline and 300 units of heparin to the patient's port and then the patient was de-accessed.No patient injury reported.

• Brand Name: DISCOFIX®
• Common Device Name: ACCESSORIES, CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 6828341
• Report Number: 2523676-2017-00122
• Device Sequence Number: 1522618
• Product Code: KGZ
• UDI-Device Identifier: 04046964183577
• UDI-Public: 04046964183577
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K760383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/01/2017

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: 12/31/2019
• Device Catalogue Number: 456003
• Device Lot Number: 17A0192042
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 MO