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

Catalog Number 4253590-01

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/07/2015

Event Type  malfunction  

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4): the nurse punctured a patient, the needle was on a tray and the shield did not close the bevel.The nurse took the needle and she got punctured.The patient has (b)(6).Hospital made analysis of the nurse and they are waiting for the results.

Manufacturer Narrative

(b)(4).No sample has been returned for investigation.The batch record could not be reviewed since the lot number is not known.Without the actual sample or lot number, a thorough investigation cannot be performed.All available information has been forwarded to the actual manufacturer.If the sample, lot number and/or additional pertinent information becomes available, a follow up report will be filed.It should be noted that the introcan safety is designed to reduce the risk of needle stick injuries.Cdc guidelines and/or facility protocols should always be followed.Sharps should be disposed of immediately into an appropriate sharps container.(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 ; GM
• Manufacturer Contact: ludwig schuetz, safety officer ; carl-braun-str.1; melsungen C-342-12 ; GM C-34212 ; 661712769
• MDR Report Key: 4740736
• MDR Text Key: 5772199
• Report Number: 9610825-2015-00150
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K982805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/24/2015,04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4253590-01
• 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: 04/24/2015
• Distributor Facility Aware Date: 04/08/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2015
• Date Manufacturer Received: 04/08/2015
• 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