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

Model Number	4251622-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
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.Note: this report is being filed as both a product problem and an adverse event due to the fact that the tip of the catheter may have remained in the patient.No intervention was done, and there was no serious injury to the patient reported, so this report has been classified only as a malfunction.
Event or Problem Description
As reported by user facility: the catheter completely detached from the hub was in the patient's vein.
Additional Manufacturer Narrative
Exemption number e2016018.(b)(4) (importer) is submitting the report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as (b)(4) internal report number (b)(4).One used sample was received for evaluation.The sample was visually inspected and it was observed that the catheter was torn off from the hub.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.The most likely cause of the observed damage is that the sample was cut with a sharp object, such as scissors or a scalpel, during use.Review of the device history record 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 or lot number.Based on the results of the investigation, no conclusions can be made regarding the cause of the reported event.If additional pertinent information becomes available a follow-up report will be filed.

• 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: 8503501
• Report Number: 9610825-2019-00104
• Device Sequence Number: 19198790
• Product Code: DYB
• UDI-Device Identifier: 04046964826023
• UDI-Public: (01)04046964826023
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K021094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2019
• Report Date (Section F): 05/07/2019

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: 08/01/2022
• Device Model Number: 4251622-02
• Device Catalogue Number: 4251622-02
• Device Lot Number: 17H11G8239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/27/2019
• Device Age: 19 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 05/07/2019
• 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: 05/07/2019