MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE FILTER 19X1-1/2 TW; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305200
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material #: 305200.Batch#: 2172517.It was reported by customer that not sure who i need to let know about this but about this sample izervay in ws: per dr.Ying, this was a non-sterile item as the filter needle that it comes with was open when he opened the box.The box was closed and sealed.Rcc received a complaint via email.Email(s) attached.Per the email from the hcp, "hello, not sure who i need to let know about this but about this sample izervay in ws: per dr.Ying, this was a non-sterile item as the filter needle that it comes with was open when he opened the box.The box was closed and sealed." item# 305200, lot#2172517.
Additional Manufacturer Narrative
(b)(4).Follow up.It was reported the blister was unsealed in an unopened kit.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos show a packaging box labeled as 'astella pharmaceutical izervay.' next to the packaging box there are two needle assembly packaging blisters labeled as 'exel.' no other information could be obtained from the photos.A device history record review was completed for provided material number 305200, lot 2172517.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 photo sample analysis the symptom reported by the customer could not be confirmed.Without the actual physical sample analysis, a probable root cause could not be offered.
Event or Problem Description
No additional information received material #: 305200, batch#: 2172517.It was reported by customer that not sure who i need to let know about this but about this sample izervay in ws: per dr.(b)(6), this was a non-sterile item as the filter needle that it comes with was open when he opened the box.The box was closed and sealed.Verbatim: rcc received a complaint via email.Email(s) attached.Per the email from the hcp, "hello, not sure who i need to let know about this but about this sample izervay in ws: per dr.(b)(6), this was a non-sterile item as the filter needle that it comes with was open when he opened the box.The box was closed and sealed." item# 305200.Lot#2172517.

• Brand Name: NEEDLE FILTER 19X1-1/2 TW
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20280475
• Report Number: 1911916-2024-00689
• Device Sequence Number: 7564401
• Product Code: GAA
• UDI-Device Identifier: 30382903052005
• UDI-Public: (01)30382903052005(11)220920(17)270630(10)2172517
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K941562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: Health Professional
• Device Catalogue Number: 305200
• Device Lot Number: 2172517
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown