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

Model Number	4251652-02
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 inc.Internal report number (b)(4).The investigation into this reported event is ongoing.Additional attempts to receive the sample are being made.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by user facility: the metal safety part on the needle did not engage completely when removed, leaving a sharp tip exposed.The nurse was stuck as a result.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).One (1) used sample and ninety-two (92) unused samples were returned for evaluation.The safety clip was observed to be dislodged on the used sample.The used and unused samples were all measured for outer diameter, crimp width, crimp length, and safety clip hold diameter, and all of the samples were within specification.Review of the device history record performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.A simulation was performed to try and determine what could have caused the issue, and when the needle was withdrawn at a fast speed and an extreme angle the results were consistent with the returned used sample.According to the ifu, during application the user should remove the needle by pulling the needle straight back with a continuous motion parallel to the skin.Although, this simulation was determined to be the most likely cause of the reported issue, no conclusions can be made regarding the cause of the reported event.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, 34212 ; GM 34212
• MDR Report Key: 9009476
• Report Number: 9610825-2019-00415
• Device Sequence Number: 11349517
• Product Code: FOZ
• UDI-Device Identifier: 04046963185206
• UDI-Public: (01)04046963185206
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K020785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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: 03/01/2024
• Device Model Number: 4251652-02
• Device Catalogue Number: 4251652-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1