MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 16X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305197
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 305197 batch # 3320201 it was reported by customer that the needles are bent at the tip and some needles broke where the needle meets the plastic.Verbatim: rcc received a complaint via phone.Pir attached.Customer states that the needles are bent at the tip and some needles broke where the needle meets the plastic.Ref number: (b)(4); lot number: 3320201.Please include (b)(6) in all communication as well as (b)(6).(b)(6) email is (b)(6).
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.H3 other text : see h10 manufacture narrative.
Event or Problem Description
No additional information received.Material # 305197, batch # 3320201.It was reported by customer that the needles are bent at the tip and some needles broke where the needle meets the plastic.Verbatim: rcc received a complaint via phone.Pir attached.Customer states that the needles are bent at the tip and some needles broke where the needle meets the plastic.Ref number: (b)(4); lot number: 3320201.Please include (b)(6) in all communication as well as (b)(6) email is (b)(6).
Additional Manufacturer Narrative
Pr 10071462 follow up.A device history record review was completed by our quality engineer team for provided material number 305197 and lot number 3320201.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.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation.It was reported the needles are bent at the tip and some needles broke where the needle meets the plastic.To aid in the investigation, eight hundred samples in sealed packaging blisters were received for evaluation by our quality team.Eighty samples were randomly selected for investigation.No defects or imperfections were observed.A device history record review was completed for provided material number 305197, lot 3320201.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 returned sample analysis the symptom reported by the customer could not be confirmed.
Event or Problem Description
No additional information received.Material # 305197 batch # 3320201.It was reported by customer that the needles are bent at the tip and some needles broke where the needle meets the plastic.Verbatim: rcc received a complaint via phone.Pir attached.Customer states that the needles are bent at the tip and some needles broke where the needle meets the plastic.Ref number: 305197; lot number: 3320201.Please include (b)(6) in all communication as well as (b)(6).

• Brand Name: NEEDLE 16X1 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: 19258302
• Report Number: 1911916-2024-00330
• Device Sequence Number: 6519336
• Product Code: FMI
• UDI-Device Identifier: 30382903051978
• UDI-Public: (01)30382903051978
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 06/13/2024

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: 305197
• Device Lot Number: 3320201
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/08/2024; 06/13/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 05/13/2024; 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown