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

Catalog Number 4251687-02

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2015

Event Type  malfunction  

Event Description

As reported by the user facility: event description: ob nurse said she started an iv ( on (b)(6) 2015) and when she pulled out the stylet the needle was poking out the side of the clip.The nurse said she was scratched by the needle but didn't want to report it or do anything about it.No patient injury.

Manufacturer Narrative

(b)(4).No sample has been returned for investigation.The batch record could not be reviewed since the lot number is not thorough investigation can not be performed.All available info has been forwarded to the actual mfr.If the sample or lot number and/or additional pertinent info becomes available, a f/u report will be filed.(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 ; carl-braun-str.1; melsungen D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 4478812
• MDR Text Key: 5498810
• Report Number: 9610825-2015-00008
• 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: 01/23/2015,01/14/2015

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: 4251687-02
• 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: 01/23/2015
• Distributor Facility Aware Date: 01/14/2015
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2015
• Initial Date Manufacturer Received: 01/14/2015
• Initial Date FDA Received: 01/23/2015
• 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