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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN SURGICAL SA HISTOACRYL BLUE 0.5ML; TISSUE ADHESIVES
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B.BRAUN SURGICAL SA HISTOACRYL BLUE 0.5ML; TISSUE ADHESIVES Back to Search Results
Model Number 1050044
Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)
Patient Problem No Patient Involvement (2645)
Event Date 10/28/2019
Event Type  malfunction  
Manufacturer Narrative
Pma/510k: reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K111959.If additional information becomes available a follow up report will be submitted.
 
Event Description
It was reported that there was ampoule leakage.The reporter indicated that when opening the package, the leakage from the ampule was already caused, therefore the product was not able to be used.
 
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Brand Name
HISTOACRYL BLUE 0.5ML
Type of Device
TISSUE ADHESIVES
Manufacturer (Section D)
B.BRAUN SURGICAL SA
121 carretera de terrassa
rubi, 08191
SP  08191
Manufacturer (Section G)
B/ BRAUN SURGICAL SA
121 carretera de terrassa
rubi, 08191
SP   08191
Manufacturer Contact
silvia orus
carretera de terrassa, 121
rubi, barcelona 08191
SP   08191
MDR Report Key9365510
MDR Text Key172459307
Report Number3003639970-2019-00806
Device Sequence Number1
Product Code MPN
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
SEE H10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/22/2019
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 Date10/31/2020
Device Model Number1050044
Device Catalogue Number1050044
Device Lot Number218481N2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/28/2019
Initial Date FDA Received11/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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