MAUDE Adverse Event Report: COLOPLAST A/S BONEE NEEDLE

Model Number	NBI0701400
Medical Device Problem Codes	Unsealed Device Packaging (1444); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Additional 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.

• Brand Name: BONEE NEEDLE
• Common Device Name: 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 Key: 13280678
• Report Number: 2125337-2022-00001
• Device Sequence Number: 5075701
• Product Code: FBK
• UDI-Device Identifier: 03600040272930
• UDI-Public: 03600040272930
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2025
• Device Model Number: NBI0701400
• Device Catalogue Number: NBI070
• Device Lot Number: 8047202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown