MAUDE Adverse Event Report: BECTON DICKINSON SAFETY GLIDE NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305917
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f27 ¿ no patient involvement.Device problem code: a0205 - packaging problem.
Event or Problem Description
Holes present in fas auto bd needle packaging- p013478 - safety glide needle (faslodex)-universal.Holes present in outer packaging compromising sterility.
Additional Manufacturer Narrative
Two photos of 21x1-1/2¿ safetyglide needles were received by bd.A quality engineer was able to review the photos from lot #2292620 regarding item #305917.Both images show sealed packages with a melt hole larger than ¼¿ by the needle hub.One image shows one needle package and the other has two needle packages.The condition observed is non-conforming per product specification.Potential root cause for the melt holes defect is associated with the packaging process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.A device history record review was completed for provided batch number 2292620 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see narrative below.
Event or Problem Description
No additional information was provided.

• Brand Name: SAFETY GLIDE NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18181797
• Report Number: 1213809-2023-01312
• Device Sequence Number: 7653026
• Product Code: FMI
• UDI-Device Identifier: 30382903059172
• UDI-Public: (01)30382903059172
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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: 305917
• Device Lot Number: 2292620
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown