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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S BONEE NEEDLE
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COLOPLAST A/S BONEE NEEDLE Back to Search Results
Model Number NBI0701400
Device Problems Unsealed Device Packaging (1444); Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2021
Event Type  malfunction  
Manufacturer Narrative
The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
 
Event Description
According to available information, a physician intended to use this needle for a botox procedure, however, it was thought that the needle was contaminated.The medical assistant stated that the peel pack that contained the sterile needle seemed to be unsealed.Procedure was finished with another needle, the original needle was discarded.No other adverse patient effects were reported.
 
Manufacturer Narrative
The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
 
Event Description
According to available information, a physician intended to use this needle for a botox procedure, however, it was thought that the needle was contaminated.The medical assistant stated that the peel pack that contained the sterile needle seemed to be unsealed.Procedure was finished with another needle, the original needle was discarded.No other adverse patient effects were reported.
 
Manufacturer Narrative
The product and a portion of the packaging were returned for evaluation.Only the paper portion of the packaging was received; in order to perform a more in-depth investigation, the foil would be needed as well.It was determined that two possible scenarios could have occurred: either the welding on the packaging wasn't thorough and there was a hole somewhere which went undetected by the operator performing 100% inspection, or, the item was received with contamination already on it.
 
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Brand Name
BONEE NEEDLE
Type of Device
NEEDLE
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA  3050
Manufacturer (Section G)
COLOPLAST A/S MANUFACTURING
9 avenue edmond rostand
sarlat-la-caneda 24206
FR   24206
Manufacturer Contact
usaby angela kilian
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key13280678
MDR Text Key286232834
Report Number2125337-2022-00001
Device Sequence Number1
Product Code FBK
UDI-Device Identifier03600040272930
UDI-Public03600040272930
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNBI0701400
Device Catalogue NumberNBI070
Device Lot Number8047202
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2021
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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