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

Catalog Number 4252527-02

Device Problem Torn Material (3024)

Patient Problems Ecchymosis (1818); Hematoma (1884)

Event Date 08/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This device has not been received for evaluation and the investigation is on going at this time.A follow up report will be provided when the inspection results become available.

Event Description

As reported by the user facility: through medwatch.The rn was attempting to start iv on medical icu patient.The vein blew and when the nurse was pulling out the iv needle and catheter, she discovered that the catheter tip had shredded.But there were no individual piece came off.The patient developed ecchymosis and a small hematoma so pressure was held.There was no other injury to the patient.Medwatch#(b)(4).

Manufacturer Narrative

(b)(4).The sample and all available information were forwarded to the manufacturer, b.Braun (b)(4).Their report states that they received one used introcan safety in opened packaging.The used sample was taken to a visual examination and observed that the capillary has penetrated the cannula.This type of defect is caused by withdrawing and reinserting the cannula into the capillary again.Based on the investigation results the defect has been deemed by the manufacturer as an application error.The instructions for use (ifu) was reviewed and found that the ifu was adequate to prevent this type of defect.According to the ifu, "after withdrawal, do not reintroduce the steel needle into the catheter, as the latter may be cut off which will lead to catheter embolism." the device history record for batch# 14l20g8231 was reviewed and there were no such defects encountered during the in process and final control inspection.If additional pertinent information becomes available, a follow-up report will be submitted.

Manufacturer Narrative

(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, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz ; carl-braun-str. 1; melsungen, 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5152362
• MDR Text Key: 28361657
• Report Number: 9610825-2015-00436
• 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,other,use
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 01/29/2016,09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 10/01/2019
• Device Catalogue Number: 4252527-02
• Device Lot Number: 14L20G8231
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2016
• Distributor Facility Aware Date: 09/23/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/29/2016; 02/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2014
• 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