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

Catalog Number 4252543-02

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems No Consequences Or Impact To Patient (2199); Needle Stick/Puncture (2462)

Event Date 05/09/2014

Event Type  malfunction  

Event Description

As reported by the user facility: customer reports: nurse had successful attempt to start iv.Safety clip did deploy.While cleaning up had a needle stick.No sample saved.

Manufacturer Narrative

(b)(4).B.Braun medical inc.Is submitting a single report on behalf of b.Braun (b)(4) (the mfr), and b.Braun medical inc.(the importer).This report has been identified as b.Braun (b)(4).In a follow up with the facility, the reporter stated that the lot number was unk and the same had been discarded.The reporter confirmed that the nurse had "labs done" and was "ok".Without the actual sample or lot number, a thorough investigation could not be performed and no specific conclusion can be drawn.Per the event description, the incident occurred during clean up.It should be noted that the introcan safety is designed to reduce the risk of needle stick injuries.However, cdc guidelines and/or facility protocols should always be followed.Sharps should be disposed of immediately into an appropriate sharps container.All available info has been provided to the actual mfr, b.Braun (b)(4) for informational purposes.If additional pertinent info becomes available, a follow up report will be submitted.

• 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: 4040148
• MDR Text Key: 4909123
• Report Number: 9610825-2014-00278
• 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: 07/17/2014,07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4252543-02
• 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: 07/17/2014
• Distributor Facility Aware Date: 07/02/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2014
• Date Manufacturer Received: 07/02/2014
• 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