MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY®; INTRODUCER, CATHETER

Model Number	4252520-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2016018 b.Braun inc.(bbmi) (importer) is submitting the report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.Attempts to get additional information and to receive the device involved in the reported event are being made.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported on medwatch mw5083446: upon removal of peripheral iv catheter in this patient's left arm,the catheter tip was missing and remained in patient's arm.Patient needed to be taken to the operating room later that night to have the catheter tip removed surgically, and this was successful.Patient doing well at the time of this report.
Additional Manufacturer Narrative
Exemption number e2016018.(b)(4) (bbmi) (importer) is submitting the report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as b.Braun medical inc.Internal report number 400420181.The actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.A simulation of the reported defect was created with a retain sample, and the in-line vision system was able to detect and reject the defective sample.This product is subjected to a 100% inspection by an in-line vision system that is calibrated and subjected to regular verifications to ensure it is functioning properly.The defect reported would have been detected and rejected by the in-line vision system.Based on the results of the investigation, no conclusions can be made regarding the cause of the reported event.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: INTROCAN SAFETY®
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 8383300
• Report Number: 9610825-2019-00033
• Device Sequence Number: 1104079
• Product Code: DYB
• UDI-Device Identifier: 04046963318178
• UDI-Public: (01)04046963318178
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K021094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2019
• Report Date (Section F): 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4252520-02
• Device Catalogue Number: 4252520-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: 02/11/2018
• Supplement Date Received by Manufacturer: 02/11/2018
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 04/04/2019