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U.S. Department of Health and Human Services

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

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B. BRAUN MELSUNGEN AG INTROCAN SAFETY I.V. SAFETY CATHETER, Back to Search Results
Catalog Number 4252527-02
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The actual device was not returned for evaluation. Without the actual sample, and or lot number a through investigation could not be performed and no specific conclusion can be drawn. Multiple attempts were made to obtain a sample and or additional information. The customer could not provide us with any additional information due to the event happened over a year ago. However, if a sample and / or additional pertinent information becomes available a follow-up report will be filed.
 
Event Description
As reported by the facility through medwatch. Event 2: 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. The nurse manager states that this is the second time that the rn's have had trouble with the 20g x 1 3/4 inch iv catheters. Medwatch #: (b)(4).
 
Manufacturer Narrative
Top right hand corner: (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. Based on the investigation results the defect was due to an application error. If additional pertinent information becomes available, a follow-up report will be submitted.
 
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Brand NameINTROCAN SAFETY
Type of DeviceI.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 Key5155602
MDR Text Key28480483
Report Number9610825-2015-00454
Device Sequence Number1
Product Code DQR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021094
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/01/2016,09/23/2015
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/16/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number4252527-02
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/01/2016
Distributor Facility Aware Date09/23/2015
Event Location Hospital
Date Report to Manufacturer02/01/2016
Date Manufacturer Received09/23/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

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