MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SAFETYGLIDE; SYRINGE, ANTISTICK

Catalog Number	305904
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the needle became completely detached from the plastic safety component.As the physical sample was not returned, a comprehensive evaluation could not be conducted.To support the investigation, four photographs were provided and reviewed by the quality team.The images depict a needle assembly with the safety mechanism engaged.The needle itself is separated from the assembly.The fourth photograph has a packaging top web labeled cardinal health.A device history record (dhr) review was completed for material number 305904, covering the potential lot numbers 2131487 and 4059264.The review did not identify any quality issues during the manufacturing of these lots that could have contributed to the reported condition.Additionally, no related quality notifications were found.All manufacturing processes and final inspections were performed in accordance with specification requirements.Based on the photographic evidence, the reported issue has been confirmed.However, due to the absence of the physical sample, a definitive root cause could not be determined.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
It was reported that the bd syringe 3ml ll w/ndl sftygld 25x5/8 rb needle pulled out of the hub.The following information was provided by the initial reporter: material#: 305904, batch#: 2131487, 4059264, 2131487, 4059264 (possible lots).Rcc received a complaint via email.Product malfunction/failure mode: defective component product description summary: i just had a conversation with xx.During an lp procedure this am the doctor was using one of the safety needles included in the kit with lidocaine and while moving the lidocaine around the needle came completely off the plastic safety part and left the needle alone attached to the patient.Clearly there was a defect with the needle.Mfg.Sku number: 305904 investigated component lot number: 2131487, 4059264, 2131487, 4059264.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• 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: 22676259
• Report Number: 1911916-2025-00547
• Device Sequence Number: 8864497
• Product Code: MEG
• UDI-Device Identifier: 00382903059041
• UDI-Public: (01)00382903059041(11)220511(17)270531(10)2131487
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2025

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: 305904
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown