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

Catalog Number	4252535-02
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The device involved has not been received for evaluation and 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: this report is for event 1: customer reports, "we experienced two needle stick injuries while using introcan safety iv catheter." the catheters involved were either an 18g (lot:18b12g8274) or 20g (lot: 0061594687).Event 1: after iv start the provider was holding the unit in their hand with the safety engaged and sustained a "bump" and the safety disengaged and impaled the provider through their glove.Event 2: the incident involving the 18g catheter will be reported via report number 9610825-2019-00375.While carrying a trash bag the provider was impaled with a used unit.Upon examination the unit's safety device was not engaged, rather half-way back on the stylet.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) picture of a used 20g introcan safety needle was returned from the customer.No samples were returned.Visual examination of the picture noted the safety clip to be sideways.The returned picture has been confirmed.Although the photo confirmed the reported defect, without the actual sample to evaluate, the exact root cause of this incident could not be determined.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: CATHETER,INTRAVASCULAR,THE
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 8917062
• Report Number: 2523676-2019-00141
• Device Sequence Number: 13513486
• Product Code: FOZ
• UDI-Device Identifier: 04046963165925
• UDI-Public: 04046963165925
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 09/25/2019

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: 05/31/2023
• Device Catalogue Number: 4252535-02
• Device Lot Number: 0061594687
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1