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

Catalog Number 4251687-02

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2014

Event Type  malfunction  

Event Description

As reported by the user facility: the locking mechanism is faulty.

Manufacturer Narrative

(b)(4).All available information has been provided to the actual manufacturer, b.Braun (b)(4).Their report states that they received two samples.For sample #1, the safety clip was activated and engaged properly on the tip of cannula.No clip deformation was observed.The used sample was checked by repositioning the clip and retesting its function and found that the clip engaged properly onto the tip of the needle.There was no rough surface/dented mark observed on cannula surface.For sample #2, the safety clip was not in engaged position and was dislodged at the middle of cannula.The used sample was checked by repositioning the clip and retesting its function and found that the clip engaged properly onto the tip of the needle.There was no abnormality found while pulling the catheter out from the cannula.The clip engaged properly onto the tip of the needle.There was no rough surface/dented mark observed on cannula surface.The returned sample #1 is g18 and returned sample #2 is g22.Based on the above test, there was no defects on the safety clips.Moreover, the assembly machine is also equipped with a vision system which conducts 100% inspection on the position of the clip in the hub.The device history record was reviewed and there were no such defect encountered during in-process inspection.Process cards show no abnormalities.If additional pertinent information becomes available, a follow report will be submitted.(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, safety officer ; carl-braun-str.1; melsungen D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 4425450
• MDR Text Key: 5373478
• Report Number: 9610825-2014-00477
• 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,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/12/2015,04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2018
• Device Catalogue Number: 4251687-02
• Device Lot Number: 3K24258231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2015
• Distributor Facility Aware Date: 04/22/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/12/2015
• Date Manufacturer Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1