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

Model Number	4252535-02
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Type of Reportable Event	Malfunction
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.Additional attempts to get the sample returned for evaluation being made.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by user facility: after the catheter was entered into the patient, the catheter leaked due to a small hole near the plastic cap.
Additional Manufacturer Narrative
Exemption number e2016018.(b)(4).This report has been identified as b.Braun medical inc.Internal report number (b)(4).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.Review of the device history record performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot 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: 7686107
• Report Number: 9610825-2018-00103
• Device Sequence Number: 16302196
• Product Code: DYB
• UDI-Device Identifier: 04046963165925
• UDI-Public: (01)04046963165925
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K021094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018
• Report Date (Section F): 08/16/2018

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: 11/01/2022
• Device Model Number: 4252535-02
• Device Catalogue Number: 4252519-02
• Device Lot Number: 17M21G8913
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/18/2018
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2018
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/16/2018