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

Catalog Number 4251652-02

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported by the user facility: event: needlestick injury.Detailed inquiry description: rn was starting iv when patient moved.Rn stuck her opposite hand (that was holding the patient down) while inserting a 20 gauge introcan safety iv catheter to the left forearm.Hospital protocols for nsi (needle stick injury) were followed.Patient testing was negative.Patient involved in the inquiry event? no.Product involved in the inquiry event? yes - disposable.When did failure occur? during therapy.A follow up with the facility was made to obtain additional and to verify the timeframe of the injury - prior to inserting, or after insertion and safety clip was not engaged or moved from needle tip.As well as to obtain status of sample yes/no?.

Manufacturer Narrative

(b)(4).B.Braun medical inc.Is submitting a single report on behalf of (b)(4) (the manufacturer), and b.Braun medical inc.(the importer).This report has been identified as b.Braun medical internal report number (b)(4).Multiple unsuccessful attempts were made to obtain a sample and lot number.No sample was returned for evaluation; because of this, further investigation of the complaint is not possible and no conclusion could be drawn.If a sample and/or any additional pertinent information becomes available, a follow up 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, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun str.1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz ; b. braun melsungen ag; carl-braun str. 1; melsungen, 34212 ; GM 34212 ; 661712769
• MDR Report Key: 5967595
• MDR Text Key: 55324257
• Report Number: 9610825-2016-00611
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2016,08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 4251652-02
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2016
• Distributor Facility Aware Date: 08/31/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2016
• Date Manufacturer Received: 08/31/2016
• 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