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

Catalog Number 4251687-02

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No samples were received for further evaluation.Multiple attempts to obtain samples, were not successful.Device history record (dhr): reviewed the device history record and no abnormalities found during in process and final control inspection.Cause could not be determined.The complaint is only taken to the knowledge and filed for statistical purpose.However, if the sample and/or any additional information becomes available the complaint will be re-opened.

Event Description

As reported by the user facility: event 2: "the catheters were jamming and not drawing back and locking for safety." per customer's feedback, "i had 2 lot numbers in stock at the same time.I'm not sure if the problems occurred with both lots.These were the introcan safety 18g angios with the lot # 16b06g8301 and 15l10g8274.We had a total of four different complaints from four different ems providers regarding these lot numbers.I was being told that once the iv was established.The providers were advancing the catheter and when withdrawing the needle the safety spring/guard would get stuck inside of the catheter hub.This resulted in the catheter having to be removed from the patient and the iv re-established." no injury.No samples.

• 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: 6042365
• MDR Text Key: 57936128
• Report Number: 9610825-2016-00655
• 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: distributor,health profession
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2016,09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4251687-02
• Device Lot Number: UNKNOWN
• 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: 10/19/2016
• Distributor Facility Aware Date: 09/23/2016
• Event Location: Other
• Date Report to Manufacturer: 10/19/2016
• Date Manufacturer Received: 09/23/2016
• 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