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

Catalog Number 4251652-02

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved was not returned for further evaluation; however a photo was received 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: problem: after inserting iv catheter, when customer went to remove the needle, the safety device did not engage properly.Photo provided.No injury.No sample.

Manufacturer Narrative

(b)(4).B.Braun medical inc.Is submitting a single report on behalf of b.Braun melsungen (the manufacturer), and (b)(4).This report has been identified as b.Braun melsungen internal report number (b)(4).One (1) photo of the failed device was received; however, based on the evaluation of the photo, the manufacture was unable to determine the cause of the incident.Multiple unsuccessful attempts were made to obtain the sample.No sample was returned for evaluation; because of this, further investigation of the complaint is not possible and no conclusion could be drawn from the photo.Hence, the complaint is assessed to be not judgable.A historical review of the complaint database identified no adverse trends for product code (b)(4) or lot number involved.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.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.

• 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: 6140760
• MDR Text Key: 61306523
• Report Number: 9610825-2016-00834
• Device Sequence Number: 1
• Product Code: DQR
• UDI-Device Identifier: 04046963185206
• UDI-Public: (01)04046963185206(17)210301(10)16C17G8316
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/23/2016,11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: 4251652-02
• Device Lot Number: 16C17G8316
• 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: 12/23/2016
• Distributor Facility Aware Date: 11/17/2016
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2016
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2016
• 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