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

Model Number	4252519-02
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.The user facility reported two potential batches 19n16g8392 & 19n13g8315, and both batches will be included in the investigation.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by user facility: started iv and connected j loop to iv catheter and fluids.A few minutes later noticed a pool of iv fluids and blood on the site.She changed the j loop to remedy, but then noticed a crack in the hub of the iv catheter.Nurse then removed the iv catheter and started a new one.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).One (1) sample was received for evaluation.When the sample was visually examined a crack was observed on the catheter hub.Simulation testing was performed to try and determine how this defect could have occurred, but the defect could not be reproduced.In order to further evaluate how the catheter hub could crack in the manner observed in the returned sample, an engineering study will be conducted.Review of the device history record performed for the reported lot numbers 19n16g8392 and 19n13g8315 did not reveal any abnormalities or non-conformances of this nature.If additional pertinent information becomes available a follow-up report will be filed.

• 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: 10298796
• Report Number: 9610825-2020-00141
• Device Sequence Number: 14109375
• Product Code: FOZ
• UDI-Device Identifier: 04046963165949
• UDI-Public: (01)04046963165949
• 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
• Report Date (Section B): 08/26/2020

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 Model Number: 4252519-02
• Device Catalogue Number: 4252519-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1