MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INTRADYN¿; INTRODUCER, CATHETER

Catalog Number	610652
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved has not yet been received for evaluation and the investigation is ongoing at this time.A follow-up report will be submitted when the results of the investigation become available.
Event or Problem Description
As reported by the user facility: event 1: excessive leaking occurred with the valve.Blood leaked back during the procedure.No adverse event reported.
Additional Manufacturer Narrative
Event 1: this report has been identified as b.Braun medical internal report number (b)(4).Two (2) used hemostasis introducer sets, with packaging, were returned for evaluation.Both returned sets were visually examined, and it was noted that both gaskets were oblong and did not close fully.Both sets were pressure tested, per specification, with leakage observed at the gasket location.Therefore, the reported defect was confirmed.In addition, the five (5) retain samples were visually and physically tested, per specification, with passing results.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.Although the defect was confirmed, the exact root cause cannot be determined at this time.We will maintain this report for further references and continue to monitor other reports for similar occurrences.

• Brand Name: INTRADYN¿
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd; allentown PA 18109
• MDR Report Key: 7135371
• Report Number: 2523676-2017-00172
• Device Sequence Number: 1311157
• Product Code: DYB
• UDI-Device Identifier: 04046964331572
• UDI-Public: 04046964331572
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K894446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

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: 09/30/2018
• Device Catalogue Number: 610652
• Device Lot Number: 0061463981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1