MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 25X5/8 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305122
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Material # 305122 , lot # 1300339.It was reported by customer that the needle is demonstrating a possible defect.They are having issues getting injections to pass through the needle and have never had this issue before.Verbatim: rcc received a complaint via email.Email(s) attached.Injuries or adverse event: no.Medline reference #: (b)(4).Item: 305122.Quantity affected: (b)(4) bx.Serial/lot number: (b)(6).Po #: (b)(4).Are any samples available for return? yes.Reported issue per customer: 4-2 customer said the needle is demonstrating a possible defect.They are having issues getting injections to pass through the needle and have never had this issue before.
Event or Problem Description
Additional information received.It was reported to supply chain that a box of bd 25g 5/8¿ needles, ref 305122 & lot 1300339, is demonstrating a possible defect.The providers are having and issues getting injections to pass through this needle and have not had this issue before.I have roughly 48 left out of the box of 100.He didn¿t record an exact number because they were not sure at first if this was an isolated error.Material # 305122 lot # 1300339.It was reported by customer that the needle is demonstrating a possible defect.They are having issues getting injections to pass through the needle and have never had this issue before.Verbatim: rcc received a complaint via email.Email(s) attached.Injuries or adverse event: no.Medline reference #: 200605848.Item: 305122 quantity affected: 1 bx.Serial/lot number: (b)(6).Po #: (b)(6).Are any samples available for return? yes.Reported issue per customer: 4-2 customer said the needle is demonstrating a possible defect.They are having issues getting injections to pass through the needle and have never had this issue before.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation.It was reported injections would not pass through needles.To aid in the investigation, ten samples in sealed packaging blisters were received for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.Each sample was then assembled to a syringe with saline solution.Each needle expelled the solution with a normal flow.A device history record review was completed for provided material number 305122, lot 1300339.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 returned sample analysis the symptom reported by the customer could not be confirmed.

• Brand Name: NEEDLE 25X5/8 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 19078244
• Report Number: 1911916-2024-00253
• Device Sequence Number: 12436350
• Product Code: FMI
• UDI-Device Identifier: 30382903051220
• UDI-Public: (01)30382903051220
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• 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): 04/18/2024

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: 305122
• Device Lot Number: 1300339
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown