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

Model Number	4252560-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/21/2019
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.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by user facility: the patient had the iv in their ac (not sure which arm) and the catheter portion broke off in the vein.This patient had to go to surgery to have the catheter portion removed.
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 400422455.One used sample was received for evaluation.The catheter was broken off, and the broken area of the catheter exhibited a clear "v" shape.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 observed in the returned sample would have been detected and rejected by the in-line vision system.Due to the clear "v" shape present on the broken catheter the most likely cause of the reported issue is the reinsertion of the needle into the catheter.The ifu clearly states, "after withdrawal, do not reintroduce the steel needle into the catheter, as the latter may be cut off".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: 8457975
• Report Number: 9610825-2019-00074
• Device Sequence Number: 16250604
• Product Code: DYB
• UDI-Device Identifier: 04046963165901
• UDI-Public: (01)04046963165901
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019
• Report Date (Section F): 06/26/2019

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: 4252560-02
• Device Catalogue Number: 4252560-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2019
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 06/26/2019
• 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
• Patient Age: 22 YR
• Date Report Sent to FDA: 06/26/2019