MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INTROCAN SAFETY; CATHETER,INTRAVASCULAR,THE

Model Number	4252535-02
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).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: it was reported that during cleanup after completing an iv insertion, the nurse was punctured on the right index finger.The safety clip was not fully covering the tip of the needle.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Based on the data from our investigation, we are unable to determine the root cause of the reported incident.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non-conformances noted during in process or final product inspection.We will maintain this report for further reference and continue to monitor other reports for similar occurrences.If additional pertinent information becomes available a follow-up report will be filed.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Based on the data from the investigation we are unable to determine the root cause of the reported incident.Although the exact root cause could not be determined, user should refer to ifu which states, "never pull the catheter back through the epidural needle due to the possibility of shearing or kinking the catheter.When removing the catheter, excessive force should never be applied.If the catheter becomes difficult to withdraw, consult standard textbooks for specific techniques.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 any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: INTROCAN SAFETY
• Common Device Name: CATHETER,INTRAVASCULAR,THE
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 10105962
• Report Number: 2523676-2020-00148
• Device Sequence Number: 3017515
• Product Code: FOZ
• UDI-Device Identifier: 04046963165925
• UDI-Public: 04046963165925
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K020785
• 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,Followup
• Report Date (Section B): 06/30/2020

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: 04/30/2024
• Device Model Number: 4252535-02
• Device Catalogue Number: 4252535-02
• Device Lot Number: 0061670100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 05/06/2020; 05/06/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 06/17/2020; 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1