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

Catalog Number 4252543-02

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 12/19/2013

Event Type  malfunction  

Event Description

As reported by the user facility: " on (b)(6), 2013, an employee engaged the safety device on this catheter and as she was placing in the sharps container the safety device disengaged exposing the needle causing a needle stick." mfr ref # 9610825-2014-00002.

• 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 (Section G): B. BRAUN MEDICAL, INC.; 901 marcon blvd.; allentown PA 18109 934
• Manufacturer Contact: 901 marcon blvd.; allentown, PA 18109-9341
• MDR Report Key: 3612385
• MDR Text Key: 4069297
• Report Number: 2523676-2014-00002
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/13/2014,12/20/2013

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 Expiration Date: 07/01/2018
• Device Catalogue Number: 4252543-02
• Device Lot Number: 3G28258393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2014
• Distributor Facility Aware Date: 12/20/2013
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1