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

Catalog Number	305200
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
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 # 1074204.It was reported by customer that the physician noticed a fiber inside the syringe body with the medication.Verbatim: rcc received a complaint via email.Email(s) attached.The physician noticed a fiber inside the syringe body with the medication.It is unknown if the fiber was present in the affected vial or if it was already present in the syringe prior to dose preparation.The affected product was not administered to a patient.No adverse event or missed doses were reported as a result of the reported event.The reporter has the affected product available for retrieval and is requesting a replacement for one eylea vial.Bd lot: 305200 / 1074204.
Additional Manufacturer Narrative
(b)(4) follow up.It was reported there was a fiber inside the syringe body.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, five photos were provided for evaluation by our quality team.The photos show a vial, a syringe and packaging labeled as 'eylea-regeneron.' no other information could be obtained from the photos.A device history record review was completed for provided material number 305200, lot 1074204.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.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
Additional information received.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No adverse events or missed doses.Material # 305200.Batch # 1074204.It was reported by customer that the physician noticed a fiber inside the syringe body with the medication.Verbatim: rcc received a complaint via email.The physician noticed a fiber inside the syringe body with the medication.It is unknown if the fiber was present in the affected vial or if it was already present in the syringe prior to dose preparation.The affected product was not administered to a patient.No adverse event or missed doses were reported as a result of the reported event.The reporter has the affected product available for retrieval and is requesting a replacement for one eylea vial.Bd lot: 305200 / 1074204.

• 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: 20332469
• Report Number: 1911916-2024-00703
• Device Sequence Number: 9574182
• Product Code: GAA
• UDI-Device Identifier: 30382903052005
• UDI-Public: (01)30382903052005(11)210426(17)260228(10)1074204
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• 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): 10/09/2024

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 305200
• Device Lot Number: 1074204
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown