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

Catalog Number 4252519-02

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 07/24/2016

Event Type  Injury  

Manufacturer Narrative

(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.Hence, the complaint is assessed to be not judgable.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 unable to be performed because the lot number was reported as unknown.

Event Description

(b)(4).Event description: an intravenous catheter broke off at the hub upon removal from a patient's left arm.The catheter piece was left in the patient's arm.Studies had to be completed to verify placement of the iv catheter and then subsequent surgical removal of the piece.Iv introcan 22 gauge catheter placed.Device will not be available for further evaluation.

• 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: 5914094
• MDR Text Key: 53483295
• Report Number: 9610825-2016-00583
• 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
• Report Date: 08/30/2016,08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4252519-02
• 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: 08/30/2016
• Distributor Facility Aware Date: 08/15/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2016
• Date Manufacturer Received: 08/15/2016
• 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