MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY® 3; CATHETER,INTRAVASCULAR,THE

Model Number	4251130-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/08/2018
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.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 was wincing when trying to place the catheter.The catheter was removed and it was then noted that the catheter had sheared in the middle.The patient was restuck without further incident.
Additional Manufacturer Narrative
Exemption number e2016018.This report has been identified as b.Braun inc.Internal report number (b)(4).Two used catheters were received for evaluation.When the two samples were visually inspected, one sample had a pierced catheter about 12mm from the needle tip, while the other sample had no evidence of damage.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.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.Although no conclusion can be made, the most likely cause of the reported event is that the needle was reinserted.The instructions for use (ifu) clearly states, "after withdrawal, do not reintroduce the steel needle into the catheter, as the latter may be cut off".If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: INTROCAN SAFETY® 3
• Common Device Name: CATHETER,INTRAVASCULAR,THE
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 7251357
• Report Number: 9610825-2018-00003
• Device Sequence Number: 1215765
• Product Code: FOZ
• UDI-Device Identifier: 04046964014055
• UDI-Public: (01)04046964014055
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K111236
• 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): 02/16/2018
• Report Date (Section F): 02/16/2018

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: 08/01/2022
• Device Model Number: 4251130-02
• Device Catalogue Number: 4251130-02
• Device Lot Number: 17H15G8373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/10/2018
• Device Age: 5 MO
• Date Report to Manufacturer: 02/16/2018
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Date Report Sent to FDA: 02/16/2018