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 06/21/2023

Event Type  malfunction  

Event Description

It was reported that 120000 bd nokor¿ filter needles had white foreign matter on their hubs.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "customer has encountered foreign matter in the bd sharp filter needles (bd part # 305200) this impacts bd lot numbers: ¿ lot 2172524 ((b)(4)) ¿ lot 2082200 ((b)(4)) additional information from customer response on (b)(6) 2023 - are you able to provide the date of the event in format dd-mmm-yyyy? o lot 2172524: (b)(6) 2023.O lot 2082200: (b)(6) 2023.- are you able to describe the foreign matter for lot #2172524 and lot # 2082200, either the foreign matter placed in cap area only or in needles/any fluid path component? lot 2172524 with black dots.Lot 2082200 with white foreign matter in needle hub downstream of filter.- was issue being described noted before, or during used? issue was noted before use.- was there any patient involvement? no.This event was initiated prior to co-packaging and labeling.- what was the patient outcome? n/a.No filter needles from these lots have been shipped to hcp¿s for administration.- was there any medical intervention due to this event? no.All units from these lots have been placed in qc hold prior to co-packaging with the drug product.No defective units have been shipped to the hcp for administration.".

Manufacturer Narrative

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

Event Description

It was reported that 120000 bd nokor¿ filter needles had white foreign matter on their hubs.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "customer has encountered foreign matter in the bd sharp filter needles (bd part # 305200).This impacts bd lot numbers: ¿ lot 2172524 (48,000 pieces).¿ lot 2082200 (120,000 pieces).Additional information from customer response on 08-03-2023.- are you able to provide the date of the event in format dd-mmm-yyyy? o lot 2172524: 25-may-2023.O lot 2082200: 21-jun-2023.- are you able to describe the foreign matter for lot #2172524 and lot # 2082200, either the foreign matter placed in cap area only or in needles/any fluid path component?.Lot 2172524 with black dots.Lot 2082200 with white foreign matter in needle hub downstream of filter.- was issue being described noted before, or during used? issue was noted before use.- was there any patient involvement? no.This event was initiated prior to co-packaging and labeling.- what was the patient outcome? n/a.No filter needles from these lots have been shipped to hcp¿s for administration.- was there any medical intervention due to this event? no.All units from these lots have been placed in qc hold prior to co-packaging with the drug product.No defective units have been shipped to the hcp for administration.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 24aug2023.H6: investigation summary: it was reported there is foreign matter in the bd sharp filter needles.To aid in the investigation, five samples in sealed packaging blisters and three photos were received for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.No foreign matter of any kind was detected in the returned samples.In the photos provided, two photos show packaging blisters with needle assemblies.The needle assemblies have specks.No other defects or imperfections were observed.The additional photo shows a document with information regarding batch numbers, acceptable quality limits and quantities.A device history record review was completed for provided material number 305200, lot 2082200.The review did not reveal any detected quality issues during the production of these lots 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 these lots.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed, but without a defective sample analysis a probable root cause could not be determined.H3 other text : see h10.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17487725
• MDR Text Key: 321716161
• Report Number: 1911916-2023-00567
• 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: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305200
• Device Lot Number: 2082200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2022
• 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