MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305917
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 305917, batch#: 4129795.It was reported that the bd safetyglide needle was clogged / blocked.The following information was provided by the initial reporter: rcc received a complaint via email.One of our xxx is reporting an issue/concern with an item that it is purchased from your company.Please include our xxx case number: (b)(4) with all email communication.Situation: issue: when injecting medication, two separate injections on the same patient, the needle seemed to get caught or stuck when giving the injection.Background: event date: 02/05/2025.Ih# and description: 93017309 needle 21gax1-1/2 safety glide 305917.Mfg#: 305917.Sample available: yes (if sample is available and would like it sent for your evaluation, please reply all, and attach a return shipping label via email).Lot#: 4129795.Assessment: credit requested: no.Po#: (b)(4).Was there injury? no.Account#: po purchased on: (b)(4).Recommendation/request: if you would like the product returned, please reply all with a return shipping label attached within 10 days that this email was sent (02/13/2025).If no label is received, product will be discarded.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - needle clogged / blocked forty-six samples were provided to our quality team for investigation.A visual inspection was performed, and no defects or imperfections were observed.Each sample was then connected to a syringe with saline solution.All the samples expelled the solution with normal flow, clogged needle was not confirmed.Furthermore, a device history record review was completed for provided batch number 4129795.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Based on the investigation and with the sample analysis the symptom reported could not be confirmed.
Event or Problem Description
No additional information was provided.

• Brand Name: BD 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: 21464977
• Report Number: 1213809-2025-00136
• Device Sequence Number: 19706027
• Product Code: FMI
• UDI-Device Identifier: 30382903059172
• UDI-Public: (01)30382903059172(11)240508(17)290430(10)4129795
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• 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): 03/18/2025

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: Health Professional
• Device Catalogue Number: 305917
• Device Lot Number: 4129795
• 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: 02/13/2025
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown