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

Catalog Number UNKNOWN

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problem Venipuncture (2129)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved has not been received for evaluation 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: "had a serious problem with introcan safety catheters 20g and 24g.The needle split from the sheath inside the patient's vein.Clinically the infusion site was painful and lasted 2 days." "issue occurred on insertion.Explained catheter separated around the needle on insertion.Patient did complain of pain during insertion removed from patient and noted catheter was split.No intervention needed on either patient.Reports he was not person who did catheter insertion so he is unsure if that person did or did not move the needle out a bit and back in searching for the vein.Customer did save the 24 gauge catheter as sample, but not the 20 gauge.".

Manufacturer Narrative

(b)(4).Multiple unsuccessful attempts were made to obtain a sample and additional information.No sample was returned for evaluation; because of this, further investigation of the complaint is not possible and no conclusion could be drawn.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: 6131449
• MDR Text Key: 61097410
• Report Number: 9610825-2016-00723
• 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: 12/19/2016,11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• 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: 11/11/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2016
• Date Manufacturer Received: 11/11/2016
• 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
• Patient Outcome(s): Other