MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NOKOR ADMIX NEEDLE; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Model Number	305216
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at least one bd nokor admix needle experienced epoxy on the device cannula.The following information was provided by the initial reporter: needles with visible white glue on needle.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: it was reported there was white glue on the hub and the needle.To aid in the investigation, three photos were provided for evaluation by our quality team.The first photo shows three packaging blisters with the product inside.No defects or imperfections are observed in this photo.The second photo shows another set of three packaging blisters with the product inside.In this photo there is a white epoxy drip over on the needle hub.The third photo shows two packaging blister top webs.This defect could occur during the assembly process.During manufacturing, the plastic hub is placed under the cannulator, then the needle is positioned and assembled to the plastic hub adding the white epoxy to fix it.After, a plastic shield is assembled.In this case, a jam may have occurred at the cannulator inducing the white epoxy drip over on the needle hub.A device history record review was completed for provided material number 305216, lot number 0115942.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the cannulator was performed.The settings were correct and the flow of product was good.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer of epoxy on the needle hub is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.We will continue monitoring the complaint trend for the product and symptom.Probable root cause: assembly line.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: it was reported there was white glue on the hub and the needle.To aid in the investigation, three photos were provided for evaluation by our quality team.The first photo shows three packaging blisters with the product inside.No defects or imperfections are observed in this photo.The second photo shows another set of three packaging blisters with the product inside.In this photo there is a white epoxy drip over on the needle hub.The third photo shows two packaging blister top webs.This defect could occur during the assembly process.During manufacturing, the plastic hub is placed under the cannulator, then the needle is positioned and assembled to the plastic hub adding the white epoxy to fix it.After, a plastic shield is assembled.In this case, a jam may have occurred at the cannulator inducing the white epoxy drip over on the needle hub.A device history record review was completed for provided material number 305216, lot number 0115942.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the cannulator was performed.The settings were correct and the flow of product was good.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer of epoxy on the needle hub is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.We will continue monitoring the complaint trend for the product and symptom.Probable root cause: assembly line.
Event or Problem Description
It was reported that at least one bd nokor admix needle experienced epoxy on the device cannula.The following information was provided by the initial reporter: needles with visible white glue on needle.
Event or Problem Description
It was reported that at least one bd nokor admix needle experienced epoxy on the device cannula.The following information was provided by the initial reporter: needles with visible white glue on needle.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-12-06.H6: investigation summary it was reported there was white glue on the hub and the needle.To aid in the investigation, twenty-eight samples in sealed packaging blisters and three photos were provided for evaluation by our quality team.A visual inspection was performed.Eight samples have an epoxy drip over on the needle hub and the other twenty samples have no defects or imperfections observed.The first photo shows three packaging blisters with the product inside.No defects or imperfections are observed in this photo.The second photo shows another set of three packaging blisters with the product inside.In this photo there is a white epoxy drip over on the needle hub.The third photo shows two packaging blister top webs.This defect could occur during the assembly process.During manufacturing, the plastic hub is placed under the cannulator, then the needle is positioned and assembled to the plastic hub adding the white epoxy to fix it.After, a plastic shield is assembled.In this case, a jam may have occurred at the cannulator inducing the white epoxy drip over on the needle hub.A device history record review was completed for provided material number 305216, lot number 0115942.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the cannulator was performed.The settings were correct and the flow of product was good.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer of epoxy on the needle hub is confirmed.H3 other text : see h10.

• Brand Name: BD NOKOR ADMIX NEEDLE
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13101725
• Report Number: 1911916-2021-01302
• Device Sequence Number: 17290615
• Product Code: GAA
• UDI-Device Identifier: 00382903052165
• UDI-Public: 00382903052165
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

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: Other
• Device Expiration Date: 06/30/2025
• Device Model Number: 305216
• Device Catalogue Number: 305216
• Device Lot Number: 0115942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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