MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 16GX1-1/2IN RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305198
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Additional 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.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 #: 305198, batch #: 3299427.It was reported by customer that there is a significant increase in vial coring when using needles in proper technique.Verbatim: rcc received a complaint via email.Email(s) attached.Product name: bd precision glide needle.Material/catalog number: 305198.Lot number(s): 3299427.Event description: date of incident (mm/dd/yyyy): ongoing.Date bd notified, if applicable (mm/dd/yyyy): 03/14/2024.Name of bd associate informed, if applicable (first and last name): n/a.Description of event (give specific and objective details of event): significant increase in vial coring when using needles in proper technique.Sample availability (yes/no including pick up detail information): no.Was there any alleged injury or harm to user or patient? (give detailed information): n/a.Additional key information: death involved yes/no, serious injury, erroneous results, exposure to blood/bodily fluid, safety issue, other type of actions taken.Safety issue; potential for significant patient harm; instructed iv staff to log specific medication vials and needles used in compounds to look for any patterns (lot and expiration).
Event or Problem Description
No additional information received.Material #: 305198, batch #: 3299427.It was reported by customer that there is a significant increase in vial coring when using needles in proper technique.Verbatim: rcc received a complaint via email.Email(s) attached.Product name: bd precision glide needle.Material/catalog number: 305198.Lot number(s): 3299427.Event description date of incident (mm/dd/yyyy): ongoing.Date bd notified, if applicable (mm/dd/yyyy): 03/14/2024.Name of bd associate informed, if applicable (first and last name): n/a.Description of event (give specific and objective details of event): significant increase in vial coring when using needles in proper technique.Sample availability (yes/no including pick up detail information): no.Was there any alleged injury or harm to user or patient? (give detailed information): n/a.Additional key information: death involved yes/no, serious injury, erroneous results, exposure to blood/bodily fluid, safety issue, other type of actions taken.Safety issue; potential for significant patient harm; instructed iv staff to log specific medication vials and needles used in compounds to look for any patterns (lot and expiration).
Additional Manufacturer Narrative
(b)(4) follow up: a device history record review was completed by our quality engineer team for provided material number 305198 and lot number 3299427.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.

• Brand Name: NEEDLE 16GX1-1/2IN 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: 18934657
• Report Number: 1911916-2024-00199
• Device Sequence Number: 4540721
• Product Code: FMI
• UDI-Device Identifier: 30382903051985
• UDI-Public: (01)30382903051985
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/27/2024

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: 305198
• Device Lot Number: 3299427
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown