MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY®; INTRODUCER, 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	11/22/2018
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).The device is currently on shipping from colombia to bbm in germany for investigation.A follow-up report will be provided after the inspection results are available.Device history record review (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 colombia): part of the catheter remained in the arm.
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).This follow up report is being filed to correct the branding, product code, and 510(k) information that was entered on the initial mdr.This report was filed for item number, 4251601-04, which is not sold in the united states, however a similar item number, 4251601-02, is sold in the united states by b.Braun medical, inc.The 510(k) has been updated to reflect a 510(k) that item 4251601-02 has been cleared under.Note: b.Braun is aware that the listed exemption has been withdrawn, however since the initial mdr report was filed under this exemption, the follow up is also being filed under the exemption.
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).We received a used capillary housing with capillary of an introcan safety pur 24g, 0.7x19mm-sa and a unused capillary housing with capillary introcan safety pur 24g, 0.7x19mm-sa without packaging.The received samples were taken to a visual examination.The introcan needle was not handed over by the customer.At the received used sample the capillary is torn off approximately 10 mm away from the capillary housing.An uneven structure is visible at the capillary in the area of the damage.The torn-off part with the capillary tip was not handed over by the customer.We exclude a production problem and assume that the capillary was torn off during the application.Therefore we assume an application error and consider the complaint not confirmed.At the second sample we detected no torn off capillary but we detected pressure points at the capillary.Summary of root cause analysis: broken off capillary defect most likely not appear to be attributed by manufacturing process as the defect is able to be detected by the in-line vision system.Damages induced after assembly process is not possible since the catheter had been protected with the protective cap.The simulation by cannula reinsertion did not produce similar defect as per complaint sample.The complaint sample defect matches with the simulation sample of being cut by sharp object such as a scissors or scalpel.The defect on the complaint sample is believed to be occurred after the cannulation process due to been cut by a sharp tool.As communicated in ifu, warning section stated that: after withdrawal, do not reintroduce the steel needle into the catheter, as the latter may be cut off, leading to catheter embolism.Do not use scissors or sharp instruments at or near the insertion site.Cause: defect due to wrong handling.

• 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: 8173828
• Report Number: 9610825-2018-00273
• Device Sequence Number: 13934500
• Product Code: DYB
• UDI-Device Identifier: 04046963166274
• UDI-Public: (01)04046963166274(17)221101(10)17M10G8393
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K021094
• 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,Followup
• Report Date (Section B): 07/02/2019
• Report Date (Section F): 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: N/A
• Device Catalogue Number: 4251601-04
• Device Lot Number: 17M10G8393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/18/2018
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 11/29/2018; 11/29/2018
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 02/07/2019; 07/02/2019
• 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: 07/02/2019