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

Catalog Number 4251628-02

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

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

Event Date 09/30/2014

Event Type  malfunction  

Event Description

As reported by the user facility: date of occurrence: (b)(6) 2014.Nurse was successful in placing iv catheter into patient.Upon securing the iv, it is believed the stylet was laying on the bed in which the needle stick injury occurred.The safety clip did not deploy.The nurse washed her hands with anti bacterial soap, applied a band aid and was sent for blood work.Patient was also tested for infectious diseases but has had a clean history this far.No patient injury.

Manufacturer Narrative

(b)(4).The actual device has not been received and the investigation is ongoing at this time.A follow up report will be submitted when the investigation results become available.(b)(4).

• Brand Name: INTROCANS SAFETY
• Type of Device: I.V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str.1; melsungen ; GM
• Manufacturer Contact: ludwig schuetz, safety officer ; carl-braun-str.1; melsungen D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 4209747
• MDR Text Key: 4964358
• Report Number: 9610825-2014-00372
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/08/2014,10/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Catalogue Number: 4251628-02
• Device Lot Number: 4C29258315
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2014
• Distributor Facility Aware Date: 10/02/2014
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2014
• Date Manufacturer Received: 10/02/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2014
• 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