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

Model Number	4254538-020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/10/2019
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).Although the batch number of the item involved in the reported incident is unknown, two potential batches were reported, 18d18g8301 and 18d09g8303.A dhr review was performed for each of the reported batches.Device history record (dhr): reviewed the dhr, there are no abnormalities found during in process and final control inspection.Sample for evaluation: received 1 used contaminated capillary hub of introcan safety-w fep 20g, 1.1x32mm-ap without packaging.Attached with the returned sample was a luer connector, presumably the customer used with the introcan safety.The cannula hub and protective cap were not returned for investigation.Investigation results: visual inspecton observed the capillary was torn off approximately 7mm from the capillary hub horn.Torn off piece of the capillary was not returned for investigation.The torn area had an uneven shape like it has been clamped.The root cause potentially due to application fault.Complaint is not confirmed.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 currently there is no serious injury to the patient, so this report has been classified only as a malfunction.
Event or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization malaysia): broken catheter tip.
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 in sections d1, d2, and g5.This report was filed for item number, 4254538-03, which is not sold in the united states, however a similar item number, 4254538-02, is sold in the united states by b.Braun medical, inc.The 510(k) has been updated to reflect a 510(k) that item 4253566-02 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.

• Brand Name: INTROCAN SAFETY®
• 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: 8432813
• Report Number: 9610825-2019-00076
• Device Sequence Number: 1330353
• Product Code: FOZ
• UDI-Device Identifier: 04046964399039
• UDI-Public: (01)04046964399039
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K020785
• 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): 07/03/2019
• Report Date (Section F): 07/03/2019

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 Model Number: 4254538-020
• Device Catalogue Number: 4254538-03
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2019
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 07/03/2019