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

Catalog Number	305905
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
The customer stated they were experiencing issues with bd safetyglide 3ml 23g x 1 syringe/needle they have received several boxes that seem to be faulty.The packages are all either opened or the seal is broken making them no longer sterile.No patient harm.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported that all packages were either opened or had broken seals.To support the investigation, the quality team received forty seven samples in an opened packaging box, along with four photographs, for evaluation.A visual inspection was performed.Thirty six samples showed no defects or imperfections, while eleven samples were received with the blister packaging already open.The sealing areas were examined under 30x magnification, and no evidence of weak seals was observed.The four photographs provided depict a subset of the received samples.A device history record review was completed for material number 305905, lot 3151049.This review did not identify any quality issues during production that could have contributed to the reported condition, and no related quality notifications were found.All manufacturing processes and final inspections met specification requirements.To date, no other similar events have been reported for this lot.Based on the investigation and returned sample evaluation, the condition reported by the customer could not be confirmed.

• Brand Name: SAFETYGLIDE LUER-LOK
• 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: 24176706
• Report Number: 1911916-2026-00039
• Device Sequence Number: 9579054
• Product Code: MEG
• UDI-Device Identifier: 00382903059058
• UDI-Public: (01)00382903059058(17)280531(10)3151049
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• 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): 02/05/2026

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: 305905
• Device Lot Number: 3151049
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown