MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INTROCAN SAFETY®; INTRODUCER, CATHETER

Catalog Number	4251644-02
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).As reported by the user facility, the sample was not available for further evaluation.Without the actual device, a thorough investigation could not be performed.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or non-conformance's of this nature.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.
Event or Problem Description
As reported by the user facility: the rn successfully inserted iv catheter.When he pulled the needle out, the safety feature did not engage and he stuck himself with a contaminated needle.No information provided on user injury and/or treatment required.No injury to patient.

• Brand Name: INTROCAN SAFETY®
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 7673326
• Report Number: 2523676-2018-00045
• Device Sequence Number: 848348
• Product Code: DYB
• UDI-Device Identifier: 04046963166007
• UDI-Public: 04046963166007
• Combination Product (Y/N): N
• PMA/510(K) Number: K020785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2018

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: 12/31/2022
• Device Catalogue Number: 4251644-02
• Device Lot Number: 0061596483
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1