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

Catalog Number	305918
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2025
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 needle sftygld 18x1-1/2 rb needle went through the shield.The following information was provided by the initial reporter: material: 305918.Batch#: 5245293.Verbatim: rcc received a complaint via email.Email(s) attached.Today a nurse brought a needle to my attention that was sticking through the plastic cap and the packaging.She felt something sharp, but no injury and it was noticed before it was used for anything.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.It was reported that the needle was protruding through the plastic cap and the packaging.To support the investigation, one sample with an opened blister pack and three photographs were provided for evaluation by the quality team.A visual inspection confirmed that the needle tip was hooked and had penetrated the plastic shield, causing damage to the shield.The photographs corresponded to the sample received.This condition may have occurred during the shielding process.A review of the device history record for material number 305918, lot 5245293, indicated that all visual inspections were performed according to requirements, with no quality notifications related to the reported condition.The lot was inspected and accepted based on the inspection control plan and subsequently approved for shipment.Additional device history records were reviewed for each batch of needles used in manufacturing this final batch, and no documentation of this type of defect was found during the entire production run.Verification of the shielding equipment confirmed that settings were correct and product flow was satisfactory.To date, no other similar events have been reported for this lot.

• 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: 23482706
• Report Number: 1213809-2025-00704
• Device Sequence Number: 21206337
• Product Code: FMI
• UDI-Device Identifier: 00382903059188
• UDI-Public: (01)00382903059188(11)250902(17)300831(10)5245293
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2025

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: 305918
• Device Lot Number: 5245293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 12/06/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown