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

Catalog Number 305200

Device Problem Contamination (1120)

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

Event Date 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

Material #: 305200.Batch #: 2082199.It was reported by customer that the tech discovered product to be covered in some sort of debris.Verbatim: rcc received a complaint via email.Email(s) attached.After opening package, and inspecting the filter needle, the tech discovered it to be covered in some sort of debris.

Manufacturer Narrative

(b)(4) follow up, a device history record review was completed by our quality engineer team for provided material number 305200 and lot number 2082199.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.

Event Description

No additional information received.Material #: 305200, batch #: 2082199.It was reported by customer that the tech discovered product to be covered in some sort of debris.Verbatim: rcc received a complaint via email.Email(s) attached.After opening package, and inspecting the filter needle, the tech discovered it to be covered in some sort of debris.

• Brand Name: NEEDLE FILTER 19X1-1/2 TW
• Type of Device: 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: 18968063
• MDR Text Key: 338755260
• Report Number: 1911916-2024-00211
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 30382903052005
• UDI-Public: (01)30382903052005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 305200
• Device Lot Number: 2082199
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1