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

Model Number 4253574-02

Device Problem Protective Measures Problem (3015)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.If additional pertinent information becomes available a follow-up report will be filed.

Event Description

As reported by user facility: safety mechanism was not activated.Nurse received needlestick injury.

• Brand Name: INTROCAN SAFETY®
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4842408332
• MDR Report Key: 8479611
• MDR Text Key: 140810378
• Report Number: 9610825-2019-00093
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 04046963318260
• UDI-Public: (01)04046963318260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4253574-02
• Device Catalogue Number: 4253574-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/03/2019
• Distributor Facility Aware Date: 03/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2019
• Date Manufacturer Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1