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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. FILTERED EXTENSION SET FILTERED EXTENSION SET WITH 1.2 MICRON FILTER

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B. BRAUN DOMINICAN REPUBLIC INC. FILTERED EXTENSION SET FILTERED EXTENSION SET WITH 1.2 MICRON FILTER Back to Search Results
Model Number FE1209F
Device Problem Air Leak (1008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Two used filtered extension sets, without packaging, were received for evaluation. Both sets were received attached to a microbore tubing set. In an attempt to replicate the reported event, the returned sample set-ups (with microbore tubing set still attached) were spiked and primed according to the instructions for use (ifu). There were no air bubbles observed within the filtered extension set tubing line or the microbore tubing set. Furthermore, the sets were subjected to occlusion and air pressure (leakage) testing according to specification with acceptable results. Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature. No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number. Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event. The returned samples met requirements according to specification, and the reported failure could not be reproduced. If additional pertinent information becomes available, a follow-up report will be filed.
 
Event Description
As reported by the user facility: event # 1: reports there have been at least two incidents of air getting in the tubing line below the filter. This is noted in the tubing line where the filter is attached.
 
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Brand NameFILTERED EXTENSION SET
Type of DeviceFILTERED EXTENSION SET WITH 1.2 MICRON FILTER
Manufacturer (Section D)
B. BRAUN DOMINICAN REPUBLIC INC.
las americas industrial park
km22 autopista las americas
santo domingo, dominican republic
DR
Manufacturer Contact
eric roden
las americas industrial park
km22 autopista las americas
santo domingo, dominican republic 
DR  
5491000
MDR Report Key5913986
MDR Text Key54273696
Report Number9614279-2016-00053
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K942988
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 12/12/2014
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Model NumberFE1209F
Device Catalogue Number473994
Device Lot Number0061389590
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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