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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PERIFIX SOFT TIP EPIDURAL CATHETER

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B. BRAUN MELSUNGEN AG PERIFIX SOFT TIP EPIDURAL CATHETER Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Information (3190)
Event Date 10/09/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). We received one used peridural catheter 20g soft tip from a perifix soft tip 901 set without packaging. The received sample was taken to a visual examination according to the test plan. The catheter end was connected with the catheter connector. Mechanical damages or manufacturing defects were not detected. The catheter tip was torn off. In this section the catheter was highly overstretched. The torn off catheter tip was not handed over by the customer. Afterwards the sample was taken to a dimensional test according to the drawing. Complete catheter length. Nominal: 1010 mm +7,50 mm/-12,50 mm. Actual: approx. 745 mm. Outside diameter of the catheter. Nominal: 0. 90 mm +0 mm/-0,06 mm. Actual: 0. 86 mm. Outside diameter in the section of the tip molding. Nominal: 0,40 mm. Actual: 0. 21 mm. During the manufacturing process the catheter will be tested 100%. It is likely that the tip has been pre-damaged during application. Afterwards the tip has been detached due to a strong axial tension. Hence assess this as a problem during application and the complaint to be not justified. The batch record could not be reviewed since the lot number is not known. If additional pertinent information becomes available, a follow up report will be submitted.
 
Event Description
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): catheter tip detached inside patient. Tip was not detected during x-ray.
 
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Brand NamePERIFIX SOFT TIP
Type of DeviceEPIDURAL CATHETER
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl-braun-str. 1
melsungen, hessen 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, hessen 34212
GM   34212
5661712769
MDR Report Key5212566
MDR Text Key30837784
Report Number9610825-2015-00523
Device Sequence Number1
Product Code DQR
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K112515
Number of Events Reported1
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 11/06/2015,10/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number4510305
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/06/2015
Distributor Facility Aware Date10/19/2015
Event Location Hospital
Date Report to Manufacturer11/09/2015
Date Manufacturer Received10/19/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/09/2015 Patient Sequence Number: 1
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