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

Catalog Number 305211

Device Problem Contamination (1120)

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

Event Date 07/07/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.6.Investigation summary: it was reported the cannula has multiple tiny particles.To aid in the investigation, one sample with no packaging blister and nine photos were provided for evaluation by our quality team.A visual inspection was performed with 10x magnification, and the needle has visible residues of lubricant applied to it.The nine photos provided show a shelf box, packaging of eylea branded products and the sample received.No other defects or imperfections were observed.This defect could occur if excess lubricant was applied to the needle during the manufacturing process.A device history record review was completed for provided material number 305211, lot 9163721.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.Verification of the lubrication application process was performed.The settings were correct, and the parts inspected were good.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.H3 other text : see h.10.

Event Description

It was reported that foreign particles were found on the bd¿ blunt fill needle with filter.The following information was provided by the initial reporter: "the reason for the complaint was that the cannula shows numerous tiny particles.".

• Brand Name: BD¿ BLUNT FILL NEEDLE WITH FILTER
• 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: 17421497
• MDR Text Key: 320510576
• Report Number: 1911916-2023-00533
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 00382903052110
• UDI-Public: 00382903052110
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305211
• Device Lot Number: 9163721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2019
• 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