MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY®; I.V. SAFETY CATHETER

Catalog Number 4251652-02

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple unsuccessful attempts were made to obtain a sample and batch number.No sample was returned for evaluation ; because of this, further investigation of the complaint is not possible and no conclusion could be drawn.Hence, the complaint is assessed to be not judgable.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.

Event Description

As reported by the user facility: a 4251652-02, date of occurrence: (b)(6) 2016.Brief inquiry description: needlestick injury, detailed inquiry description, evs staff was scratched by used, activated introcan safety shield after the stylets had been left in the trash.Patient involved in the inquiry event? no.Product involved in the inquiry event? yes - disposable.Customer reported event to authority, unknown.Samples available? no.When did failure occur? unknown.

• Brand Name: INTROCAN SAFETY®
• Type of Device: I.V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun str.1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun str.1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz ; b. braun melsungen ag; carl-braun str. 1; melsungen, 34212 ; GM 34212 ; 661712769
• MDR Report Key: 5949169
• MDR Text Key: 54664057
• Report Number: 9610825-2016-00610
• Device Sequence Number: 1
• Product Code: DQR
• 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: 09/14/2016,08/31/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 4251652-02
• 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: 09/14/2016
• Distributor Facility Aware Date: 08/31/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2016
• Initial Date Manufacturer Received: 08/31/2016
• Initial Date FDA Received: 09/14/2016
• 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