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	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd 18 g bd nokor¿ 5 micron filter needle experienced shipping box or inside units are wet.The following information was provided by the initial reporter: customer got in a case from bd that has 4 cases inside: 2 cases of 303018, 1 case of 381167, 1 case of 305201.The case of 305201 is wrapped in plastic, the box is soaked in what smells like vinegar.The main box isn¿t a repack box and it¿s not wet.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd 18 g bd nokor¿ 5 micron filter needle experienced shipping box or inside units are wet.The following information was provided by the initial reporter: customer got in a case from bd that has 4 cases inside: 2 cases of 303018, 1 case of 381167, 1 case of 305201.The case of 305201 is wrapped in plastic, the box is soaked in what smells like vinegar.The main box isn¿t a repack box and it¿s not wet.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 13-sep-2023.Investigation summary: it was reported the box is wrapped in plastic and is soaked in what smells like vinegar.To aid in the investigation, one case box in a plastic bag and three photos were provided for evaluation by our quality team.The cardboard of the case box received is wet and has a strong smell like vinegar.The three photos provided show the sample received.No other defects or imperfections were observed.This defect could occur during the transportation or storage of the unit.The product received is not in the condition the product leaves the manufacturing facility.At the manufacturing site, the case boxes are not wrapped in plastic bags as it was reported when received.A notification to the distribution center was made regarding this complaint.A device history record review was completed for provided material number (b)(4), lot 3083412.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.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 is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17746732
• Report Number: 1911916-2023-00665
• Device Sequence Number: 17165162
• Product Code: GAA
• UDI-Device Identifier: 00382903052011
• UDI-Public: 00382903052011
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

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: 3083412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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