MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SAFETYGLIDE; 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	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd safetyglide needles had packaging with questioned sterility.The following information was provided by the initial reporter translated from (b)(6) to english: recently, while using this batch of needles, we have discovered a large number of substandard products, with the specific batch number of 3047907.To date, more than 90 problematic needles have been picked out, with problems including but not limited to a large number of black dots inside the package, missing protection devices, damaged and missing outer packaging, and bent needles, etc additional information provided: 1."black dots inside the package" were these black dots noted on the outside of the device(s)? outside device and inside the package.2."damaged and missing outer packaging" were the seals of the packaging compromised? yes.
Additional Manufacturer Narrative
(b)(4).- supplemental mdr - sterility questioned.Ninety-three samples and four photos of safetyglide needles (part number 305917, batch 3047907) were received and evaluated.Five samples were found acceptable with no defects.Eighty-three samples contained unknown particulate matter inside the packaging.Two syringes showed brownish discoloration on the needle shield due to embedded foreign matter.Additional defects included one sample with a melt hole in the bottom web compromising sterility, one with a severely bent needle, and one with a broken shield.The submitted photos confirmed these findings, including one missing needle shield and visible foreign particulates.All observed conditions are non-conforming per product specifications.Potential root cause for the foreign matter non-fluid path internal to package, shield damaged and melt hole defect is associated with the packaging process, while the presence of embedded degraded resin is linked to the molding process.Furthermore, a device history record review was completed for provided lot number 3047907.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.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.
Event or Problem Description
No additional information was provided.

• Brand Name: SAFETYGLIDE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21693966
• Report Number: 1213809-2025-00215
• Device Sequence Number: 8774314
• Product Code: FMI
• UDI-Device Identifier: 30382903059172
• UDI-Public: (01)30382903059172(11)230216(17)280131(10)3047907
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: Other
• Device Catalogue Number: 305917
• Device Lot Number: 3047907
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown