MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN® SAFETY; I.V. SAFETY CATHETER

Model Number	N/A
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2016018 b.Braun medical, inc.(importer) is submitting this report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as b.Braun melsungen ag internal report # (b)(4).A follow-up report will be provided after the inspection results are available.Device history record (dhr) : reviewed the device history record and no abnormalities found during in process and final control inspection.
Event or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in japan): the clip was missing.
Additional Manufacturer Narrative
Exemption number e2016018 b.Braun medical, inc.(importer) is submitting this report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as b.Braun melsungen ag internal report # (b)(4).Received one used sample of introcan safety pur 22g, 0.9x25mm-ap in an opened packaging.Lot number printed on returned package was 16l12g8361 and material # 4251628-03.The catheter hub was not returned for investigation.It was observed that the safety clip was missing.Summary of root cause analysis: - two scratch lines along cannula body towards cannula bevel were observed.- these scratch lines showed the evidence of clip travel along the cannula.- cannula crimping dimension for the complaint sample are within specification.- production historical data on crimp width, clip pull off force and clip hole diameter does not showed any adverse trend.- assembly machine has online vision system to conduct 100% checking on relevant critical dimension of cannula including crimp width, crimp length, clip dimension, clip position and present of clip.All the defective parts will be automatically rejected by machine.- ipqc and final control also conducted clip functional test as well as product completeness check.- safety clip detached from cannula able ot be s simulated by turning the catheter hub then lift up the cannula in extreme angle during cannula withdrawal.- however, during application user should remove the cannula by pulling cannula straight back with a swift, continuous motion parallel to the skin (according to ifu).- the clip was missing and catheter hub was not returned for futher evaluation.- hence, the root cause could not be determined.

• Brand Name: INTROCAN® SAFETY
• Common Device Name: I.V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 6368478
• Report Number: 9610825-2017-00043
• Device Sequence Number: 10873489
• Product Code: DQR
• UDI-Device Identifier: 04046963166021
• UDI-Public: (01)04046963166021(17)211001(10)16L12G8361
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K982805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2017
• Report Date (Section F): 06/26/2017

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: 10/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 4251628-03
• Device Lot Number: 16L12G8361
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/17/2017
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 06/26/2017
• 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: 06/26/2017