MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NOKOR¿ FILTER NEEDLE; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number 305200

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2023

Event Type  malfunction  

Event Description

It was reported that foreign matter was found inside 2 bd nokor¿ filter needle kits during an inspection prior to use.The following information was provided by the initial reporter: "on (b)(6) 2023, an initial retains exam and component examination was performed in on item 8148200419.Foreign particulate was located inside of the filter needle.Of two kits.There was a total of 120 retain samples inspected with two kits affected by this defect.Affected items were segregated from the rest of lot and marked for observation.This observation is not related to a product complaint reported.As this is drug product component, this was not used in a manufacturing process.The raw material was shipped from bd to sharp.".

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 19-may-2023.H6: investigation summary: it was reported there was foreign matter located inside the filter needle.To aid in the investigation, two samples in sealed packaging blisters and two photos were provided for evaluation by our quality team.A visual inspection was performed, and one sample has a 1/64" black embedded particle in the needle hub.The other sample has a 1/128" black particle embedded in the plastic shield.The two photos provided show the samples received.No other defects or imperfections were observed.The embedded degraded resin in the component typically occurs at the startup or intermittently during the injection molding process.The degraded resin can break loose and be molded into components.A device history record review was completed for provided material number 305200, lot 1074204.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

Event Description

It was reported that foreign matter was found inside 2 bd nokor¿ filter needle kits during an inspection prior to use.The following information was provided by the initial reporter: "on 04apr2023, an initial retains exam and component examination was performed in on item 8148200419.Foreign particulate was located inside of the filter needle.Of two kits.There was a total of 120 retain samples inspected with two kits affected by this defect.Affected items were segregated from the rest of lot and marked for observation.This observation is not related to a product complaint reported.As this is drug product component, this was not used in a manufacturing process.The raw material was shipped from bd to sharp.".

• Brand Name: BD NOKOR¿ FILTER NEEDLE
• Type of Device: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• 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 ; 8448235433
• MDR Report Key: 16920681
• MDR Text Key: 315123937
• Report Number: 1911916-2023-00302
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 00382903052004
• UDI-Public: 00382903052004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305200
• Device Lot Number: 1074204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1