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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/10/2017
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).No sample has been returned for investigation.Without the actual sample (or device), a thorough investigation could not be performed and no specific conclusion can be drawn as to the cause of the reported event.A review of the batch and manufacturing records revealed no abnormalities or nonconformities.H3 other text : device not returned to manufacturer.
Event or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in brazil ): broken/catheter.
Additional Manufacturer Narrative
Exemption number e2016018.(b)(4).We received one used capillary housing with capillary of an introcan safety pur 14g, 2.2x50mm-sa in open packaging.The introcan needle was not handed by the customer.The received sample was taken to a visual inspection.At the returned sample the capillary is detached from the capillary housing.Investigation revealed the defect was most likely due to the capillary with metal bush being pulled out of the catheter hub at the manufacturing station.Changes have already been made to the affected station in april 2015.No subsequent complaints of this type of defect have been received for this machine.

• 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: 6630150
• Report Number: 9610825-2017-00107
• Device Sequence Number: 815920
• Product Code: DQR
• UDI-Device Identifier: 04046964382123
• UDI-Public: (01)04046964382123(17)190701(10)14G10G8244
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K982805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018
• Report Date (Section F): 01/04/2018

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: 07/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 4251717-04
• Device Lot Number: 14G10G8244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2018
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: 05/19/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 01/04/2018
• 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: 01/04/2018