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

Catalog Number 4251652-02

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Needle Stick/Puncture (2462); No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2014

Event Type  malfunction  

Event Description

As reported by the user facility: event 2 - customer reports: some nurse had 2 needle stick injuries, one on (b)(6) 2014 and one 10 days later.Nurse was successful in starting the iv without any difficulties.The nurse set the needle on the bed next to other materials and while cleaning up brushed hand over the bed and was stuck in the left palm.The nurse was not sure if the shield totally deployed or not, but believes it did.The second incident occurred the same way, but was stuck in the right palm.Nurse reports this is the process he always performs as they admit at least 30 patients per day.No pt injury.

Manufacturer Narrative

(b)(4).The actual device has been received and the investigation is ongoing at this time.A f/u report will be submitted under mfr #: 2523676-2014-00411.(b)(4).

• Brand Name: INTROCAN SAFETY
• Type of Device: I.V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str.1; melsungen 3421 2; GM 34212
• Manufacturer Contact: ludwig schuetz, safety officer ; carl-braun-str.1; melsungen D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 4290456
• MDR Text Key: 5082067
• Report Number: 9610825-2014-00412
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/13/2014,10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• 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: 14E26G8361
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/12/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2014
• Distributor Facility Aware Date: 10/27/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2014
• Date Manufacturer Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• 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