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

Catalog Number 456003

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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®
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 6828341
• MDR Text Key: 83937932
• Report Number: 2523676-2017-00122
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 04046964183577
• UDI-Public: 04046964183577
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K760383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 456003
• Device Lot Number: 17A0192042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 26 MO