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 09/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report has been identified as b.Braun medical internal report number (b)(4).Multiple unsuccessful attempts were made to obtain a sample.No sample was returned for evaluation; because of this, further investigation of the complaint is not possible.Hence, the complaint is assessed to be not judgable.If a sample, lot number and/or any additional pertinent information becomes available, a follow up will be submitted.

Event Description

As reported by the user facility: ref # unknown introcan safety catheter, lot # unknown.Reports, safety clip did deploy as removed from catheter, but became hung up in nurses glove as she set it down dislodging the clip and allowing a needle stick through the finger tip.Patient preformed iv start on was know to be (b)(6).Nurse will require follow up blood work over next several months.No patient injury.No sample available.

Manufacturer Narrative

(b)(4).Multiple unsuccessful attempts were made to obtain a sample.No sample was returned for evaluation ; because of this, further investigation of the complaint is not possible and no conclusion could be drawn.Device history record (dhr): review of the device history records was performed and no non conformances or deviations were noted in process and final inspection.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: 5967625
• MDR Text Key: 55324432
• Report Number: 9610825-2016-00624
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2016,09/08/2016

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 Expiration Date: 05/01/2021
• Device Catalogue Number: 4251652-02
• Device Lot Number: 16E10G8316
• 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: 12/19/2016
• Distributor Facility Aware Date: 09/08/2016
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2016
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2016
• 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