MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INTROCAN SAFETY®; INTRODUCER, CATHETER

Catalog Number	4252535-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Vasculitis (2004); Foreign Body In Patient (2687)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Although it was confirmed that the device involved is not available for evaluation, the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Event or Problem Description
As reported by the user facility: patient had a septoplasty and smr at the ent surgery center where he had an iv catheter place in the left wrist.Iv was discontinued that day and removed post-surgery.11 days later the patient went to the emergency room.The patient stated in the er, an ultrasound was performed and showed a retained iv catheter in the left wrist.He was referred to an orthopedic surgeon.The administrator stated he had no idea the patient had complained of pain in his left wrist.The patient came in for surgery on (b)(6) 2018 for a septoplasty with smr.Patient had a successful procedure.The nurse who placed the iv in the left wrist was successful and witnessed by the administrator.The same nurse removed the iv post-surgery.The nurse reported that the iv was intact when removed.There was no resistance, no complications noticed.Patient had no signs or symptoms of phlebitis or other ill effects from the iv catheter.Patient was later discharged with no complications from the iv or surgery.The patient confirmed that he went to the emergency room 11 days later with complaints of signs and symptoms of phlebitis.The emergency room did an ultrasound and noted a catheter tip retained in the left wrist.Denies any culture obtained.The emergency room did not give results of ultrasound.It is undetermined how many centimeters retained in the patient.Patient had a surgical consult, it is undetermined if patient will undergo surgery.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was returned for evaluation.Without the actual device, a thorough investigation could not be performed.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: INTROCAN SAFETY®
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 8148477
• Report Number: 2523676-2018-00104
• Device Sequence Number: 2266359
• Product Code: DYB
• UDI-Device Identifier: 04046963165925
• UDI-Public: 04046963165925
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K021094
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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: 01/31/2023
• Device Catalogue Number: 4252535-02
• Device Lot Number: 0061601142
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 01/24/2019
• 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
• Patient Age: 30 YR
• Patient Weight: 86