MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 18X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305196
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
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 #:305196, batch#: 3271975.It was reported by customer that every use of this lot of needles is causing coring of the vial and bag stoppers.No adverse event.
Event or Problem Description
No additional information received material #: 305196.Batch#: 3271975.It was reported by customer that every use of this lot of needles is causing coring of the vial and bag stoppers.Verbatim: complaint received via email(s) attached.Email from phsa: hi vendor rep, please follow up with (b)(6) for the product concern outlined below within 3 business days; and advise of any special shipping instructions for pick up, courier or discarding of product.Please investigate and follow up with a written report from your quality assurance as to your findings and resolutions.Product concern ticket number: (b)(4) date of incident: (b)(6)2024 hospital: (b)(6).Department: pharmacy.Product: precision glide needle 18g x 1 1/2 in.Vmid: (b)(4) lot number: 3271975.Product expiry date: 30-nov-2028.Number of defective product(s): (b)(4) is sample available: yes.Concern description: every use of this lot of needles is causing coring of the vial and bag stoppers.Thank you in advance for your follow-up on this product concern.Email from (b)(6): hello, we have received the below product problem report.(b)(6) ref#(b)(4) has been assigned to this issue.Upon completion, please provide a quality investigation letter detailing your findings.Please advise on next steps for quality investigation and customer resolution: product problem report product information product code: 305196 product description: needle hypo 18 x 1.5in rb bx/100 lot/serial #: (b)(6).Expiry date: 2028-11-30.Problem information **cite customer complaint #(b)(4) ** every use of this lot of needles is causing coring of the vial and bag stoppers occurrences: (b)(4) each.Reporter information reporter name: (b)(6).Reporter position/department: pharmacy.Reporter phone: (b)(6).Reporter email: (b)(6).Site information (b)(6).Sample information incident samples: (b)(4).Representative samples: 0.No adverse event reported.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation it was reported the needles are causing coring of the vials and bag stoppers.To aid in the investigation, seven samples in sealed packaging blisters were received for evaluation by our quality team.A visual inspection was performed with 30x magnification.There was no damage, defective grind or hooks observed.The bevels and etch were good.A device history record review was completed for provided material number 305196, lot 3271975.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.

• Brand Name: NEEDLE 18X1-1/2 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: 20235640
• Report Number: 1911916-2024-00674
• Device Sequence Number: 12752846
• Product Code: FMI
• UDI-Device Identifier: 30382903051961
• UDI-Public: (01)30382903051961(11)230928(17)281130(10)3271975
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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: 305196
• Device Lot Number: 3271975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown