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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PF2000; FILTER .2 MICRON

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B. BRAUN MELSUNGEN AG PF2000; FILTER .2 MICRON Back to Search Results
Catalog Number 415002
Device Problems Failure to Deliver (2338); No Flow (2991)
Patient Problem Patient Problem/Medical Problem (2688)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved has 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: event: no flow with several filters after iv line primed, also had occurrences during infusion that there was no flow.No samples of used product.Will retain 1 sterile sample.No patient injury reported.
 
Manufacturer Narrative
(b)(4).Five (5) unused samples were tested using bubble point and liquid flow rate test, and based on the testing results, the filters passed the required specifications during testing.The lot history records were reviewed for the reported lot number 12840647, and confirmed to have been manufactured and released according to specifications meeting all quality control requirements with no deviations detected.If any additional pertinent information becomes available, a follow up will be submitted.
 
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Brand Name
PF2000
Type of Device
FILTER .2 MICRON
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 Key5967569
MDR Text Key55325800
Report Number9610825-2016-00615
Device Sequence Number1
Product Code FPB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K941589
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,Followup
Report Date 11/01/2016,09/06/2016
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 Health Professional
Device Expiration Date06/30/2019
Device Catalogue Number415002
Device Lot Number12840647
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/01/2016
Distributor Facility Aware Date09/06/2016
Event Location Hospital
Date Report to Manufacturer11/01/2016
Initial Date Manufacturer Received 09/06/2016
Initial Date FDA Received09/21/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/01/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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