MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 18 G BD NOKOR¿ 5 MICRON FILTER NEEDLE

Catalog Number	305201
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter facility name: (b)(6) manufacturing.Investigation summary: it was reported there was discoloration on a package.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows packaging blister top webs with part of the graphics with light printing.No other defects or imperfections were observed.This defect could occur if the printer equipment had low ink inducing the symptom reported.A device history record review was completed for provided material number 305201, lot number 1273791.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 top web printing process was performed.The settings, alignment and printing graphics were all acceptable.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 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.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.We will continue monitoring the complaint trend for the product and symptom.
Event or Problem Description
It was reported that 3 bd 18 g bd nokor¿ 5 micron filter needles experienced discolored packaging.The following information was provided by the initial reporter: we received the batch with a discoloration of the sterilization method on the primary packaging.

• Brand Name: BD 18 G BD NOKOR¿ 5 MICRON FILTER NEEDLE
• Common Device Name: FILTER NEEDLE
• 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: 14714170
• Report Number: 1911916-2022-00302
• Device Sequence Number: 17411768
• Product Code: GAA
• UDI-Device Identifier: 00382903052011
• UDI-Public: 00382903052011
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 05/26/2022

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 Catalogue Number: 305201
• Device Lot Number: 1273791
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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