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

Model Number	4251717-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
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 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 discrepancy management system database 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.If additional information becomes available, a follow up report will be submitted.
Event or Problem Description
As reported by user facility: the catheter would not advance and as tension was let off the catheter slid back onto the needle.The needle was removed from the catheter to engage the safety apparatus and then the catheter was removed from the patient and it was noticed that a portion of the tip of the catheter was sheared off.
Additional Manufacturer Narrative
Exemption number e2016018.(b)(4).This report has been identified as b.Braun medical inc.Internal report number (b)(4).One used device was received for evaluation.Upon receipt the actual device involved was visually inspected.The visual examination revealed that the tip of the catheter had been cut.The type of cut that was observed can be made by the needle if it pierces the catheter.This product is subjected to a 100% inspection by a 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.The most likely cause of the reported event is that the needle was reinserted.The ifu clearly states, " after withdrawal, do not reintroduce the steel needle into the catheter, as the latter may be cut off".Review of the discrepancy management system database 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.If additional information becomes available, a follow up report will be submitted.

• Brand Name: INTROCAN SAFETY®
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, 34212 ; GM 34212
• MDR Report Key: 6844735
• Report Number: 9610825-2017-00176
• Device Sequence Number: 1511536
• Product Code: DYB
• UDI-Device Identifier: 04046963189105
• UDI-Public: (01)04046963189105
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2017
• Report Date (Section F): 10/12/2017

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: 02/01/2022
• Device Model Number: 4251717-02
• Device Catalogue Number: 4251717-02
• Device Lot Number: 17B24G8264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2017
• Initial Date Received by Manufacturer: 08/08/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 10/12/2017
• 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: 10/12/2017